Device product
DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
Z-2160-2020
Product summary
- Event
- Event 85436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 units
- Official record key
device-enforcement:Z-2160-2020
Official wording
Reason: There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.
Code information: Batch: 1378830/Expiration Date: September 8, 2022; Batch: 1379253/Expiration Date: August 13, 2022; Batch: 1380094/Expiration Date: August 22, 2022; Batch: 1381695/Expiration Date: October 30, 2022
Distribution pattern: US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY OUS: Argentina, Australia, Austria, Belgium, Canada, Chile, Costa Rica, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Latvia, Liechtenstein, Luxembourg, Netherlands, New Zealand, Peru, Portugal, Serbia, Singapore, South Africa, Spain, Thailand, United Kingdom
Derived failure modes
-
Unknown
There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage.