FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 1854454
·
Received September 30, 2010
Report
- Report Number
- 2937094-2010-00620
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- August 6, 2010
- Report Date
- September 2, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 THE FIBER CAP DETACHED INSIDE OF THE PT AT 234,921 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. AND IT WAS REPORTED THAT THE PT HAD SOME BLEEDING COMPLICATIONS AFTER THE FIBER CAP DETACHMENT BUT NO PT INJURIES WERE OCCURRED. THE DEVICE WAS NOT RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT ADDSTAT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY | NA | 014H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |