FDA Adverse Event
Malfunction
Summary report: N
CONMED
MDR report key: 2410568
·
Received January 5, 2012
Report
- Report Number
- MW5023753
- Event Type
- Malfunction
- Date Received
- January 5, 2012
- Date of Event
- December 8, 2011
- Report Date
- January 5, 2012
- Manufacturer
- CONMED CORPORATION
- Product Code
- LKF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONMED UTERINE MANIPULATOR PIECES WERE DETACHED FROM THE DEVICE IN PT AS IT WAS BEING REMOVED. ALL PIECES WERE ACCOUNTED FOR. CURRENT LOT CODES IN HOUSE: 1111011; 1110251; 1110031; 1107251; 1108312; 1103011; 1106152; 1103291; AND 1107121.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED | UTERINE MANIPULATOR | LKF | CONMED CORPORATION | CURRENT LOT# LISTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |