FDA Adverse Event
Malfunction
Summary report: N
GREENLIGHT ADDSTAT
MDR report key: 2031208
·
Received March 16, 2011
Report
- Report Number
- 2937094-2011-00441
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- September 24, 2010
- Report Date
- December 29, 2010
- Manufacturer
- AMS INNOVATION CENTER-SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFO REGARDING THIS COMPLAINT WAS RECEIVED ON (B)(6) 2011 WHICH INDICATED THAT AN MDR WAS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010, THE FIBER TIP DETACHED DURING CLEANING AT 115,238 JOULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT ADDSTAT | SURGICAL FIBER | GEX | AMS INNOVATION CENTER-SILICON VALLEY | NA | 004H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |