FDA Adverse Event
Summary report: N
*
MDR report key: 2903303
·
Received December 27, 2012
Report
- Report Number
- 2903303
- Date Received
- December 27, 2012
- Date of Event
- November 28, 2012
- Report Date
- December 27, 2012
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORPORATION
- Product Code
- FAJ
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
STORZ LIGHT CORD WAS IN AN OLYMPUS CYSTOSCOPE SET. THE CORD IS NOT COMPATIBLE WITH THE SCOPE. CAN BE MADE TO FIT WITH AN ADAPTER, BUT TEMPERATURE IS NOT THE SAME IN THE LIGHT, AND PATIENT COULD POTENTALLY BE BURNED. ISSUE WAS DISCOVERED PRIOR TO USE IN PATIENT AND A CORRECT CORD WAS FOUND AND USED, SO NO HARM.IT IS IMPERATIVE THAT THE BRAND AND NUMBER ON CORDS BE CHECKED WHEN ASSEMBLING SETS - BOTH LIGHT CORDS ARE GREY AND LOOK VERY SIMILAR, BUT ARE NOT INTERCHANGEABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | CYTOSCOPE | FAJ | OLYMPUS MEDICAL SYSTEMS CORPORATION | 11FR | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |