FDA Adverse Event
Malfunction
Summary report: N
ANGLED DELIVERY DEVICE, GREENLIGHT
MDR report key: 2440526
·
Received January 19, 2012
Report
- Report Number
- 2937094-2012-00066
- Event Type
- Malfunction
- Date Received
- January 19, 2012
- Date of Event
- August 24, 2011
- Report Date
- December 26, 2011
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER THAT ON (B)(6) 2011 THE FIBER FORWARD FIRED AT 97,888 JOULES. ADD'L INFO REPORTED BY THE CUSTOMER WAS THE BEAM WAS USED TO TEST THE FIBER PRIOR TO USE INSIDE OF THE PT. THE BEAM WAS VISIBLE. DURING THE PROCEDURE, THERE WERE NO ERROR CODES THAT WERE DISPLAYED ON THE CONSOLE WHEN THE EVENT OCCURRED. THE PT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THE INCIDENT. THE USER DID NOT EXPERIENCE ANY INJURY FROM THE USE OF THE SYSTEM. THE CURRENT STATUS OF THE PT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED DELIVERY DEVICE, GREENLIGHT | SURGICAL FIBER | GEX | AMERICAN MEDICAL SYSTEMS, INC. | 0010-2090 | 106H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GREENLIGHT SURGICAL LASER SYSTEM| ACCESSORIES |