Device product
5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Z-1283-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 67710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55,521 ea. in total
- Official record key
device-enforcement:Z-1283-2014
Official wording
Reason: Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
Code information: Product Code: 405910RC, Lot Numbers: 01J1200010, 01J1200242, 01K1200070, 01A1300141, 01B1300052, and 01D1300319.
Distribution pattern: Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
Derived failure modes
-
Unknown
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.