FDA Adverse Event
Malfunction
Summary report: N
STONELIGHT
MDR report key: 1211752
·
Received October 21, 2008
Report
- Report Number
- 1211752
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 21, 2008
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
LASER MACHINE FAILED TO OPERATE PROPERLY. WHEN FOOT PEDAL WAS INITIATED IT WORKED WELL AND SUDDENLY STOPPED WORKING. PROCEDURE TERMINATED WITH ARRANGEMENTS FOR FOLLOW UP WAVE LITHOTRIPSY. BIOMEDICAL ENGINEERING ASSESSMENT OF PROBLEM: LASER FAILED TO FUNCTION DURING CASE. CONTRACTED EQUIPMENT OWNER/OPERATOR IDENTIFIED PROBLEM AS THE FOOT SWITCH CABLE.RECOMMENDATION: CONNECTOR ON THE FOOTSWITCH CABLE (WHERE IT CONNECTS TO THE LASER) WAS DAMAGED. BIOMED HAD DONE A SAFETY INSPECTION OF THE LASER PRIOR TO THE CASE, BUT THE DAMAGED CONNECTOR WAS NOT SEEN. IT IS THE VENDOR'S RESPONSIBILITY TO CHECK THE FUNCTIONALITY OF THEIR EQUIPMENT PRIOR TO A CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STONELIGHT | LASER, HOLMIUM, UROLOGICAL | GEX | AMERICAN MEDICAL SYSTEMS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |