FDA Adverse Event
Malfunction
Summary report: N
MONOPOLAR CORD, STERILE SINGLE USE
MDR report key: 4994511
·
Received August 7, 2015
Report
- Report Number
- 1530493-2015-00005
- Event Type
- Malfunction
- Date Received
- August 7, 2015
- Date of Event
- October 18, 2013
- Report Date
- August 3, 2015
- Manufacturer
- OLSEN MEDICAL LLC
- Product Code
- GEI
- UDI-DI
- +M111920021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NOT RETURNED.
Description of Event or Problem · 1
THE END OF THE DEVICE WAS LOOSE ON THE TUR CONNECTOR CORD AND THEREFORE COULD NOT BE USED. DEVICE DID NOT FUNCTION AS INTENDED. DEVICE STOPPED WORKING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520985 | MONOPOLAR CORD, STERILE SINGLE USE | CABLE/CORD | GEI | OLSEN MEDICAL LLC | 92002 | +M111920021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |