FDA Adverse Event
Injury
Summary report: N
STERIS
MDR report key: 2123402
·
Received December 15, 2008
Report
- Report Number
- 2123402
- Event Type
- Injury
- Date Received
- December 15, 2008
- Date of Event
- October 27, 2008
- Report Date
- October 29, 2008
- Manufacturer
- STERIS CORP.
- Product Code
- FQO
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OPERATING ROOM TABLE BEING LOWERED AFTER LEG VEIN HARVEST, WHEN BOTH HEAD AND LEG PORTION BEGAN TO RAISE PUTTING PATIENT IN "U SHAPED" POSITION. OPERATOR UNABLE TO LOWER TABLE. PATIENT WAS DRAPED AND TRANSFERRED TO ANOTHER OPERATING ROOM TABLE. SURGERY ABORTED GIVEN QUESTION OF PATIENT SAFETY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERIS | STERIS SURGICAL TABLE | FQO | STERIS CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |