FDA Adverse Event
Injury
Summary report: N
POWERED LASER SURGICAL SYSTEMS
MDR report key: 2774423
·
Received September 28, 2012
Report
- Report Number
- 2937094-2012-00977
- Event Type
- Injury
- Date Received
- September 28, 2012
- Date of Event
- September 6, 2012
- Report Date
- September 6, 2012
- Manufacturer
- AMERICAN MEDICAL SYSTEMS
- Product Code
- GEX
- PMA / PMN Number
- K062719
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE THE LASER SYSTEM DISPLAYED ERRORS INDICATIVE OF A SYSTEM MALFUNCTION. THE CUSTOMER ATTEMPTED TO CLEAR THE ERROR HOWEVER ERRORS REOCCURRED. THE CUSTOMER DETERMINED THE LASER SYSTEM COULD NO LONGER BE UTILIZED AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE SURGICAL PROCEDURE (TURP). THERE WAS NO REPORT OF A PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERED LASER SURGICAL SYSTEMS | LASER SYSTEM | GEX | AMERICAN MEDICAL SYSTEMS | 0010-0070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |