Device product
Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050.
Z-1898-2025
Product summary
- Event
- Event 96755
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-1898-2025
Official wording
Reason: Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Code information: Model/REF Number: 5863050. UDI-DI: B33158630500. Lot Number: M28186. Serial Numbers: 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059
Distribution pattern: US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Derived failure modes
-
Unknown
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.