Device product
5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, 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-1285-2014
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-1285-2014
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: 405912R, Lot Numbers: 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136.
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.