MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-28 for KLEPPINGER FORCEPS 8383.21.1, 8384.21.1 manufactured by Richard Wolf Medical Instrument Corp..
[19697945]
The forceps is attached to a bipolar cord at the back of the instrument. The procedure is performed. Then, when the cord is removed from the forceps for cleaning, part of the forceps breaks off and remains stuck inside the bipolar cord. It costs the facility $658. 00 to replace the two items. (see also 1003524. )
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003523 |
| MDR Report Key | 16465 |
| Date Received | 1994-09-28 |
| Date of Report | 1994-09-07 |
| Date of Event | 1994-09-06 |
| Date Added to Maude | 1994-09-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KLEPPINGER FORCEPS |
| Product Code | FJR |
| Date Received | 1994-09-28 |
| Catalog Number | 8383.21.1, 8384.21.1 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16398 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-28 |