FDA Adverse Event
Malfunction
Summary report: N
FORCEPS CEV134 BIPOLAR 350MM MOUIEL [MXI/XOM]
MDR report key: 3211193
·
Received July 8, 2013
Report
- Report Number
- 9680837-2013-00014
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 14, 2013
- Manufacturer
- XOMED MICROFRANCE MFG
- Product Code
- GEI
- PMA / PMN Number
- K993655
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE OBSERVATION OF THE BREAK DOES NOT EMPHASIZE A CORRODED AREA, INDICATING THAT THE CASE WAS SUDDEN. THE EDGES OF THE BREAK INDICATE THAT THE JAW SUFFERED A SIDE STRAIN. NO MANUFACTURING DEFECT HAS BEEN FOUND. THE ELECTRODE HAS MOST LIKELY BEEN EXPOSED TO EXCESSIVE LATERAL CONSTRAINT DURING USE OR REPROCESSING.
Description of Event or Problem · 1
IT WAS REPORTED ONE OF THE JAWS OF THE ELECTRODE IS BROKEN. THERE IS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309627 | FORCEPS CEV134 BIPOLAR 350MM MOUIEL [MXI/XOM] | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | XOMED MICROFRANCE MFG | CEV134 | 130305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |