FDA Adverse Event
Malfunction
Summary report: N
STERIS RAPTOR GRASPING DEVICE
MDR report key: 13734237
·
Received March 10, 2022
Report
- Report Number
- MW5108030
- Event Type
- Malfunction
- Date Received
- March 10, 2022
- Report Date
- March 8, 2022
- Manufacturer
- US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC.
- Product Code
- OCZ
- UDI-DI
- 00724995183653
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RAPTOR GRASPING DEVICE #00711177 LOT#2200981 X2. FAULTY GARBAGE. FAULTY RIGHT OUT OF THE BAG. FDA SAFETY REPORT ID #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 823555 | STERIS RAPTOR GRASPING DEVICE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | US ENDOSCOPY / UNITED STATES ENDOSCOPY GROUP, INC. | 00711177 | 2200981 | 00724995183653 |
| 823556 | STERIS RAPTOR GRASPING DEVICE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | US ENDOSCOPY /UNITED STATES ENDOSCOPY GROUP, INC. | 00711177 | 2200981 | 00724995183653 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |