FDA Adverse Event
Malfunction
Summary report: N
MONOPOLAR CONNECTING CABLE
MDR report key: 1033008
·
Received April 22, 2008
Report
- Report Number
- 1418479-2008-00013
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 26, 2008
- Report Date
- April 22, 2008
- Manufacturer
- RICHARD WOLF GMBH
- Product Code
- IKD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BOTH CABLES WERE DESTROYED BY ENDUSER. WITHOUT PRODUCT, THERE CANNOT BE A COMPLETE INVESTIGATION.
Description of Event or Problem · 1
DURING A LAP COLE PROCEDURE, TWO CABLES SMOKED AND THEN BURNED AT THE BASE OF THE CONNECTOR. ANOTHER CABLE WAS USED FOR THE PROCEDURE. BOTH CABLES WERE DESTROYED. THERE WAS NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOPOLAR CONNECTING CABLE | MONOPOLAR CONNECTING CABLE | IKD | RICHARD WOLF GMBH | 8106.033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |