FDA Adverse Event
Other
Summary report: N
DUSTOME
MDR report key: 963467
·
Received July 7, 2006
Report
- Report Number
- 2914019-2006-00058
- Event Type
- Other
- Date Received
- July 7, 2006
- Date of Event
- June 9, 2006
- Report Date
- July 7, 2006
- Manufacturer
- LUMENIS
- Product Code
- GEX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS OF 07/07/06, IT APPEARS THAT THE FIBER WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INVESTIGATION IS POSSIBLE. CORRECTED INFORMATION: ON THE END USER FACILITY MEDWATCH REPORT, THE DEVICE MFR IS INCORRECTLY LISTED AS BOSTON SCIENTIFIC CORP. THE MFR OF THE DUOTOME 550 FIBER IS LUMENIS.
Description of Event or Problem · 1
FIBER OVERHEATED AND STOPPED WORKING AFTER 8000 JOULES. VOLUNTARY MDR PROCESSED, NO ADVERSE EVENTS, PT CONDITION FINE. PROCEDURE COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE (VIPER TRODE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUSTOME | HO YAG/ND YAG SURGICAL LASER FIBER DELIVERY DEVICE | GEX | LUMENIS | DUOTOME 550 | 35811205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | PER USER FACILITY MDR: OTHER THERAPIES IN USE ON| PATIENT: NOT KNOWN.| PER USER FACILITY MDR: OTHER DEVICES IN USE ON PT:| NONE KNOWN. |