Device product
Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Z-2278-2020
Product summary
- Firm
- Genicon, Inc.
- Event
- Event 85407
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 (6 boxes with 5 units/per box in inventory)
- Official record key
device-enforcement:Z-2278-2020
Official wording
Reason: There is potential for the plastic optical tip to become detached from the metal shaft.
Code information: Lot I8086-C
Distribution pattern: US consignees in AL, DE, FL, GA, MO, NC, TN Foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand
Derived failure modes
-
Unknown
There is potential for the plastic optical tip to become detached from the metal shaft.