FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED)
MDR report key: 1732203
·
Received June 7, 2010
Report
- Report Number
- 2936485-2010-00454
- Event Type
- Malfunction
- Date Received
- June 7, 2010
- Date of Event
- May 24, 2010
- Report Date
- May 24, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- HRR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. A SIMILAR PRODUCT FROM LOT # 846006 WAS ALSO IMPLICATED IN THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCISSORS WERE DULL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED) | SCISSORS | HRR | STRYKER ENDOSCOPY SAN JOSE | 0944669E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |