FDA Adverse Event
Malfunction
Summary report: N
TRIVEX SYSTEM ILLUMINATOR-HANDPIECE
MDR report key: 1913117
·
Received November 14, 2010
Report
- Report Number
- 1913117
- Event Type
- Malfunction
- Date Received
- November 14, 2010
- Date of Event
- October 20, 2010
- Report Date
- November 4, 2010
- Manufacturer
- SMITH & NEPHEW
- Product Code
- DWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE LIGHT ON THE TRIVEX MACHINE WAS VERY DIM FOR THE CASE. WE CHECKED THE MACHINE, WE SWITCHED THE LIGHT CORD, THEN THE ILLUMINATOR WITH NO SUCCESS. WE SWITCHED OUT THE MACHINE TO USE THE LOANER. THERE WAS A SIGNIFICANT DIFFERENCE IN THE LIGHT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NOT APPLICABLE====================== MANUFACTURER RESPONSE FOR TRIVEX SYSTEM ILLUMINATOR-HANDPIECE, TRIVEX SYSTEM ILLUMINATOR-HANDPIECE======================AWAITING RESPONSE====================== MANUFACTURER RESPONSE FOR FIBER OPTIC CABLE, FIBER OPTIC CABLE======================AWAITING RESPONSE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIVEX SYSTEM ILLUMINATOR-HANDPIECE | TRIVEX SYSTEM ILLUMINATOR-HANDPIECE | DWQ | SMITH & NEPHEW | 7210351 | NA | |
| 2 | FIBER OPTIC CABLE | FIBER OPTIC CABLE | DWQ | SMITH & NEPHEW | 7205180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |