FDA Adverse Event
Malfunction
Summary report: N
ACCUFLEX (273 MICRON)
MDR report key: 1170346
·
Received September 8, 2008
Report
- Report Number
- 1170346
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 18, 2008
- Report Date
- September 8, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP. (UROLOGY)
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC HOLMIUM LASER FIBER 273 MICRON, ACCUFLEX SNAPPED IN HALF DURING USE. FIBER BROKE APPROXIMATELY 6" FROM MACHINE (NOT IN CONTACT WITH PATIENT). THE LASER WAS TURNED OFF AND REMOVED FROM THE FIELD. ANOTHER FIBER USED WITHOUT INCIDENT. NO HARM TO PATIENT.THE HOLMIUM LASER WAS CHECKED BY CLINICAL TECH, AND NO PROBLEMS WERE NOTED WITH IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCUFLEX (273 MICRON) | LASER FIBER | GEX | BOSTON SCIENTIFIC CORP. (UROLOGY) | * | TRF2957F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |