FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL PLUS S/I ES STRAIGHT HANDPIECE
MDR report key: 1120064
·
Received August 15, 2008
Report
- Report Number
- 1320894-2008-00121
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- June 26, 2008
- Report Date
- August 14, 2008
- Manufacturer
- CONMED CORPORATION
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT WAS REPORTED BY CONMED (B) (4), AND WAS STATED TO HAVE OCCURRED AT (B) (6) HOSPITAL IN (B) (6). THE QUALITY ENGINEER IS CURRENTLY EXAMINING THE RETURNED DEVICE. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT "AFTER BEING USED FOR A SHORT PERIOD OF TIME, THE SUCCION CLAPET STUCK IN THE OPEN POSITION AND BEGAN TO EMPTY THE PNEUMOPERITONEUM".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL PLUS S/I ES STRAIGHT HANDPIECE | S/I ELECTROSURGICAL HANDPIECE | GEI | CONMED CORPORATION | NA | 0804221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |