Device product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Z-1481-2022
Product summary
- Event
- Event 90493
- Status
- Completed
- Classification
- Class II
- Quantity
- 3392
- Official record key
device-enforcement:Z-1481-2022
Official wording
Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Code information: UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.
Distribution pattern: United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico.
Derived failure modes
-
Unknown
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.