FDA Adverse Event
Malfunction
Summary report: N
MICROFRANCE® INSTRUMENT
MDR report key: 3960404
·
Received July 28, 2014
Report
- Report Number
- 9680837-2014-00062
- Event Type
- Malfunction
- Date Received
- July 28, 2014
- Date of Event
- June 30, 2014
- Report Date
- July 3, 2014
- 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
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: ANALYSIS FOUND THAT ONE OF THE CERAMIC PLATES IS BROKEN. THE BROKEN FRAGMENT HAS NOT BEEN RETURNED. HOWEVER, NO EVENT WAS REPORTED AND THIS FILE IS A STANDARD REPAIR REQUEST. THE INSTRUMENT HAS BEEN RETURNED WITH THE PROVIDED PROTECTION HOLDER. THE BREAKAGE IS PROBABLY DUE TO A SHOCK DURING REPROCESSING OR USE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ¿CERAMIC PLATE IS BROKEN¿. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439347 | MICROFRANCE® INSTRUMENT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | XOMED MICROFRANCE MFG | CEV625H | 110704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |