FDA Adverse Event
Other
Summary report: N
GREENLIGHT PV ADDSTAT
MDR report key: 2214066
·
Received August 2, 2011
Report
- Report Number
- 2937094-2011-01561
- Event Type
- Other
- Date Received
- August 2, 2011
- Date of Event
- February 6, 2006
- Report Date
- June 29, 2011
- Manufacturer
- AMS, INNOVATION CENTER - SILICON VALLEY
- Product Code
- GEX
- PMA / PMN Number
- K010284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFO RECEIVED INDICATED AN MDR WAS REQUIRED ON (B)(6) 2011. THE AMOUNT OF JOULES USED HAVE BEEN REPORTED AS 278,813 JOULES. THIS AMOUNT OF JOULES IDENTIFIED THAT THIS FIBER WAS USED TO ITS MAXIMUM ALLOWABLE JOULE LIMIT. FIBER CAP DEGRADATION WOULD BE CONSIDERED NORMAL WEAR AND NOT A FIBER MALFUNCTION.
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2006 THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 278,813 JOULES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GREENLIGHT PV ADDSTAT | SURGICAL FIBER | GEX | AMS, INNOVATION CENTER - SILICON VALLEY | NA | 545D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |