FDA Adverse Event
Malfunction
Summary report: N
STRYKER ENDOSCOPY
MDR report key: 2614768
·
Received May 29, 2012
Report
- Report Number
- MW5025734
- Event Type
- Malfunction
- Date Received
- May 29, 2012
- Date of Event
- May 11, 2012
- Report Date
- May 24, 2012
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SUCTION IRRIGATOR STARTED TO SMOKE, IRRIGATOR THROWN OFF FIELD, NO HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER ENDOSCOPY | STRYKER FLOW II - SURGICAL IRRIGATOR | GEI | STRYKER ENDOSCOPY | 250-070-500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other |