FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS ELECTRODE
MDR report key: 3060636
·
Received March 26, 2013
Report
- Report Number
- 9610773-2013-00030
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- February 26, 2013
- Report Date
- February 27, 2013
- Manufacturer
- OLYMPUS WINTER & IBE GMBH
- Product Code
- FAS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
OLYMPUS FOLLOWED UP WITH THE REPORTER TO OBTAIN MORE DETAILED INFO REGARDING THE REPORT WITH NO RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED. THIS REPORT WILL BE SUPPLEMENTED IF ADD'L AND SIGNIFICANT INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
OLYMPUS WAS INFORMED THAT THE DISTAL END OF THE ELECTRODE BROKE OFF IN THE MIDDLE OF AN UNSPECIFIED PROCEDURE. THE BROKEN PIECE WAS NOT RETRIEVED DUE TO LACK OF VISUALIZATION. THERE WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122994 | OLYMPUS ELECTRODE | ELECTRODE | FAS | OLYMPUS WINTER & IBE GMBH | WA22603D | 982098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |