FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 2073627
·
Received April 13, 2011
Report
- Report Number
- 2937094-2011-00648
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 21, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEM, INNOVATION CENTER - SILCON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER AIMING BEAM FIRED STRAIGHT AND THE FIBER CAP DETACHED WHILE INSIDE OF THE PT AT 72,607 JOULES. ALSO, IT WAS REPORTED THAT ALL PIECES WERE RETRIEVED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT ADDSTAT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEM, INNOVATION CENTER - SILCON VALLEY | NA | 017H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |