FDA Adverse Event
Injury
Summary report: N
5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED)
MDR report key: 1812018
·
Received August 18, 2010
Report
- Report Number
- 2936485-2010-00644
- Event Type
- Injury
- Date Received
- August 18, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 30, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- LRW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT BROKE DURING A LAPAROSCOPIC PROCEDURE. IT WAS FURTHER REPORTED THAT THE BROKEN FRAGMENT WAS ABOUT 1-2 MM IN SIZE AND WAS STILL IN THE BODY OF THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED) | SCISSORS | LRW | STRYKER ENDOSCOPY SAN JOSE | 0846009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other |