FDA Adverse Event
Malfunction
Summary report: N
ENDO RETRACT II
MDR report key: 1191876
·
Received October 8, 2008
Report
- Report Number
- 1191876
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- September 9, 2008
- Report Date
- October 8, 2008
- Manufacturer
- COVIDIEN UNITED STATES SURGICAL CORPORATION
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
Narratives
Description of Event or Problem · 1
BLACK PLASTIC COATING HAD COME OFF THE INSTRUMENT AND WAS FOUND IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO RETRACT II | RETRACTOR, SURGICAL | GAD | COVIDIEN UNITED STATES SURGICAL CORPORATION | * | P8B0196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |