FDA Adverse Event
Injury
Summary report: N
ENDOCOAGULATOR
MDR report key: 19125
·
Received January 25, 1995
Report
- Report Number
- MW1004860
- Event Type
- Injury
- Date Received
- January 25, 1995
- Date of Event
- January 6, 1995
- Report Date
- January 9, 1995
- Manufacturer
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- Product Code
- FEH
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
UPON COMPLETION OF CASE, A BLANCHED AREA WAS NOTED ON THE TOP PORTION OF THE UTERO-SACRAL LIGAMENT DUE TO MALFUNCTION OF ENDO COAGULATION PROBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOCOAGULATOR | SEMM POINT COAGULATOR | FEH | KARL STORZ ENDOSCOPY-AMERICA, INC. | 30627PA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Other| R |