Device product
Ethicon Endo-Surgery Inc. The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. Model Numbers: NSLG2C14 NSLG2C25 NSLG2C35 NSLG2C45 NSLG2514 NSLG2S25 NSLG2S35 NSLGS545
Z-0758-2013
Product summary
- Event
- Event 64055
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58,338 Instruments
- Official record key
device-enforcement:Z-0758-2013
Official wording
Reason: Potential for self activation while the device is in use, which may result in unintended thermal damage.
Code information: Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017. Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017. Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017, Lot # J4AX37, Exp. Date 5-2017, Lot # J4AX5Z, Exp. Date 5-2017, Lot # J4AX6E, Exp. Date 5-2017, Lot # J4AX8T, Exp. Date 5-2017, Lot # J4AX8U, Exp. Date 5-2017, Lot # J4AZ3P, Exp. Date 6-2017, Lot # J4AZ3V, Exp. Date 6-2017, Lot # J4AZ4W, Exp. Date 6-2017, Lot # J4AZ51, Exp. Date 6-2017, Lot # J4C11M, Exp. Date 6-2017, Lot # J4C11H, Exp. Date 6-2017, Lot # J4C15E, Exp. Date 6-2017, Lot # J4C17G, Exp. Date 6-2017, Lot # J4C174, Exp. Date 6-2017, Lot #, J4C187, Exp. Date 6-2017, Lot # J4C197, Exp. Date 6-2017, Lot # J4C17Y, Exp. Date 6-2017, Lot # J4C19M, Exp. Date 6-2017, Lot #, J4C225, Exp. Date 6-2017, Lot # J4C22H, Exp. Date 6-2017, Lot # J4C358, Exp. Date 6-2017, Lot # J4C35C, Exp. Date 6-2017, Lot # J4C36T, Exp. Date 6-2017, Lot # J4C427, Exp. Date 7-2017, Lot # J4C42D, Exp. Date 7-2017, Lot # J4C44P, Exp. Date 7-2017, Lot # J4C51U, Exp. Date 7-2017, Lot # J4C51W, Exp. Date 7-2017, Lot # J4C56E, Exp. Date 7-2017, Lot # J4C56A, Exp. Date 7-2017, Lot # J4C56Z, Exp. Date 7-2017, Lot # J4C56P, Exp. Date 7-2017, Lot # J4C58J, Exp. Date 7-2017, Lot # J4C58V, Exp. Date 7-2017, Lot # J4C65M, Exp. Date 7-2017, Lot # J4C66A, Exp. Date 7-2017, Lot # J4C66L, Exp. Date 7-2017, Lot # J4C758, Exp. Date 7-2017, Lot # J4C768, Exp. Date 7-2017, Lot # J4C85H, Exp. Date 7-2017, Lot # J4C85W, Exp. Date 7-2017, Lot # J4C906, Exp. Date 7-2017, Lot # J4C96P, Exp. Date 8-2017, Lot # J4C96Z, Exp. Date 8-2017, Lot # J4C879, Exp. Date 7-2017, Lot # J4CA4X, Exp. Date 8-2017, Lot # J4CA4Y, Exp. Date 8-2017, Lot # J4CC01, Exp. Date 8-2017, Lot # J4CC2G, Exp. Date 8-2017, Lot # J4CC4J, Exp. Date 8-2017, Lot # J4CD0C, Exp. Date 8-2017, Lot # J4CE10, Exp. Date 8-2017, Lot # J4CE16, Exp. Date 8-2017, Lot # J4CF0J, Exp. Date 8-2017, Lot # J4CF66, Exp. Date 9-2017, Lot # J4CJ0L, Exp. Date 9-2017, Lot # J4CJ5Z, Exp. Date 9-2017, Lot # J4CJ6J, Exp. Date 9-2017 and Lot # J4CK1K, Exp. Date 9-2017. Product Code NSLG2C45, Lot # H44W26, Exp. Date 10-2013, Lot # H44W25, Exp. Date 10-2013, Lot # H44W27, Exp. Date 10-2013, Lot # J4A19D, Exp. Date 12-2013, Lot # J4AR6G, Exp. Date 4-2017, Lot # J4AU2R, Exp. Date 5-2017, Lot # J4AV5U, Exp. Date 5-2017, Lot # J4AZ53, Exp. Date 6-2017, Lot # J4C042, Exp. Date 6-2017, Lot # J4C122, Exp. Date 6-2017, Lot # J4C18F, Exp. Date 6-2017, Lot # J4C23J, Exp. Date 6-2017, Lot # J4C270, Exp. Date 6-2017, Lot # J4C32F, Exp. Date 6-2017, Lot # J4C62J, Exp. Date 7-2017, Lot # J4C62P, Exp. Date 7-2017, Lot # J4C816, Exp. Date 7-2017, Lot # J4C90E, Exp. Date 7-2017, Lot # J4C90F, Exp. Date 7-2017, Lot # J4C99K, Exp. Date 8-2017, Lot # J4CA8M, Exp. Date 8-2017, Lot # J4CD6Z, Exp. Date 8-2017, Lot # J4CJ73, Exp. Date 9-2017 and Lot # J4CK5E, Exp. Date 9-2017. Product Code NSLG2S14, Lot # H44Z5R, Exp. Date 11-2013, Lot # J4C312, Exp. Date 6-2017, Lot # J4C639, Exp. Date 7-2017 and Lot # J4CG7Z, Exp. Date 9-2017. Product Code NSLG2S25, Lot # H44Z57, Exp. Date 11-2013, Lot # J4AU2W, Exp. Date 5-2017, Lot # J4AW4P, Exp. Date 5-2017, Lot # J4AW4N, Exp. Date 5-2017, Lot # J4AX4W, Exp. Date 5-2017, Lot # J4AZ5M, Exp. Date 6-2017, Lot # J4C09V, Exp. Date 6-2017, Lot # J4C18R, Exp. Date 6-2017, Lot # J4C22J, Exp. Date 6-2017, Lot # J4C27C, Exp. Date 6-2017, Lot # J4C34E, Exp. Date 6-2017, Lot # J4C34F, Exp. Date 6-2017, Lot # J4C34K, Exp. Date 6-2017, Lot # J4C37R, Exp. Date 6-2017, Lot # J4C49E, Exp. Date 7-2017, Lot # J4C49G, Exp. Date 7-2017, Lot # J4C576, Exp. Date 7-2017, Lot # J4C577, Exp. Date 7-2017, Lot # J4C63W, Exp. Date 7-2017, Lot # J4C67U, Exp. Date 7-2017, Lot # J4C75N, Exp. Date 7-2017, Lot # J4C75X, Exp. Date 7-2017 and Lot # J4C92G, Exp. Date 7-2017. Product Code NSLG2S35, Lot # H44Y6N, Exp. Date 11-2013, Lot # H44Y8A, Exp. Date 11-2013, Lot # H44Y8K, Exp. Date 11-2013, Lot # H44Z65, Exp. Date 11-2013, Lot # H44Z6J, Exp. Date 11-2013, Lot # J4A164, Exp. Date 12-2013, Lot # J4AR9C, Exp. Date 4-2017, Lot # J4AT1U, Exp. Date 4-2017, Lot # J4AT22, Exp. Date 4-2017, Lot # J4AT4H, Exp. Date 4-2017, Lot # J4AU2X, Exp. Date 5-2017, Lot # J4AW31, Exp. Date 5-2017, Lot # J4AW36, Exp. Date 5-2017, Lot # J4AW9D, Exp. Date, 5-2017, Lot # J4AW9H, Exp. Date, 5-2017, Lot # J4AX62, Exp. Date, 5-2017, Lot # J4AX8Y, Exp. Date, 5-2017, Lot # J4AX9F, Exp. Date, 5-2017, Lot # J4C100, Exp. Date, 6-2017, Lot # J4C109, Exp. Date, 6-2017, Lot # J4C15H, Exp. Date, 6-2017, Lot # J4C18W, Exp. Date, 6-2017, Lot # J4C209, Exp. Date, 6-2017, Lot # J4C20A, Exp. Date, 6-2017, Lot # J4C23K, Exp. Date, 6-2017, Lot # J4C27E, Exp. Date, 6-2017, Lot # J4C27H, Exp. Date, 6-2017, Lot # J4C32G, Exp. Date, 6-2017, Lot # J4C34M, Exp. Date, 6-2017, Lot # J4C435, Exp. Date, 7-2017, Lot # J4C43J, Exp. Date, 7-2017, Lot # J4C537, Exp. Date, 7-2017, Lot # J4C53G Exp. Date, 7-2017, Lot # J4C53T, Exp. Date, 7-2017, Lot # J4C57N, Exp. Date, 7-2017, Lot # J4C57P, Exp. Date, 7-2017, Lot # J4C64N, Exp. Date, 7-2017, Lot # J4C64U, Exp. Date, 7-2017, Lot # J4C73T, Exp. Date, 7-2017, Lot # J4C73X, Exp. Date, 7-2017, Lot # J4C914, Exp. Date, 7-2017, Lot # J4C90W, Exp. Date, 7-2017, Lot # J4C92Z, Exp. Date, 7-2017, Lot # J4CE93, Exp. Date, 8-2017 and Lot # J4CC02, Exp. Date, 8-2017. Product Code NSLG2S45, Lot # J4A12R, Exp. Date 12-2013, Lot # J4AV6G, Exp. Date 5-2017, Lot # J4AV6T, Exp. Date 5-2017, Lot # J4AX9V, Exp. Date 5-2017, Lot # J4C15V, Exp. Date 6-2017, Lot # J4C30V, Exp. Date 6-2017, Lot # J4C37T, Exp. Date 6-2017, Lot # J4C67E, Exp. Date 7-2017, Lot # J4C67J, Exp. Date 7-2017, Lot # J4C67M, Exp. Date 7-2017, Lot # J4C74T, Exp. Date 7-2017 and Lot # J4CC9G, Exp. Date 8-2017.
Distribution pattern: Worldwide Distribution - USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.
Derived failure modes
-
Unknown
Potential for self activation while the device is in use, which may result in unintended thermal damage.