FDA Adverse Event
Malfunction
Summary report: N
COHERENT
MDR report key: 3029391
·
Received January 23, 2013
Report
- Report Number
- 3029391
- Event Type
- Malfunction
- Date Received
- January 23, 2013
- Date of Event
- January 22, 2013
- Report Date
- January 23, 2013
- Manufacturer
- CLINICAL RESEARCH CONSULTANTS, INC.
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
DURING LASER USE, LASER FAULTED AND STOPPED DELIVERING TREATMENT (FAULT 205 AND FAULT 201, AND "ALL LASERS MALFUNCTIONING"). NEW FIBERS WERE USED (REF # 101130, LOT # A12-0308-B/EXP. 2016-08-08 AND REF # 101130 LOT # A13-0036-B/EXP. 2016-09-23) WITH SAME RESULT. DIFFERENT LASER WAS OBTAINED AND NO TREATMENT WAS PRODUCED WITH THE SECOND LASER. NURSE NOTIFIED AND LASER REPRESENTATIVE NOTIFIED BY HER. REP BROUGHT IN SECOND LASER AND WAS PRESENT AT END OF PROCEDURE. PROCEDURE WAS ABORTED DUE TO MALFUNCTIONING LASER; BASKET THAT WAS IN USE (SECURED AROUND THE STONE) WAS CUT AND LEFT IN PLACE DUE TO NOT BEING ABLE TO FRAGMENT THE STONE WITH THE LASER. STENT AND FOLEY WERE PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 33819 | COHERENT | POWERED LASER SURGICAL | GEX | CLINICAL RESEARCH CONSULTANTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |