MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-17 for 46300223 manufactured by Richard Wolf Medical Instrument.
[21972674]
Cysto resecting sheath started to spark at distal end during surgery. The procedure was discontinued and patient was assessed with no harm. Equipment removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038760 |
| MDR Report Key | 4198994 |
| Date Received | 2014-10-17 |
| Date of Report | 2014-10-17 |
| Date of Event | 2014-09-15 |
| Date Added to Maude | 2014-10-27 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BIVAP ELECTRODE |
| Product Code | FDC |
| Date Received | 2014-10-17 |
| Model Number | 46300223 |
| Lot Number | 453111 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENT |
| Manufacturer Address | VERNON HILLS 60061 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-17 |