FDA Adverse Event
Malfunction
Summary report: N
FIBER ONE
MDR report key: 1944130
·
Received December 29, 2010
Report
- Report Number
- 2937094-2010-01435
- Event Type
- Malfunction
- Date Received
- December 29, 2010
- Date of Event
- December 3, 2010
- Report Date
- December 7, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K100746
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER END FIRED AT 18,733 JOULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIBER ONE | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | NA | 043A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |