FDA Adverse Event
Malfunction
Summary report: N
HANDLE F/MONOPOLAR ELECTRODES 5MM
MDR report key: 6425697
·
Received March 22, 2017
Report
- Report Number
- 9610612-2017-00156
- Event Type
- Malfunction
- Date Received
- March 22, 2017
- Date of Event
- February 17, 2017
- Report Date
- March 22, 2017
- Manufacturer
- AESCULAP AG
- Product Code
- GEI
- PMA / PMN Number
- K970541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DEVICE NOT RETURNED.
Description of Event or Problem · 0
COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE INSULATION BECAME RED HOT AT THE CONNECTION OF THE INSULATION AND HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206171 | HANDLE F/MONOPOLAR ELECTRODES 5MM | ENDOSCOPY | GEI | AESCULAP AG | GK372R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Congenital Anomaly |