MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for KNIFE ELECTRODE manufactured by Richard Wolf Gmbh.
[74437397]
Patient Sequence No: 1, Text Type: N, H10
[74437398]
During a transurethral prostate resection and cystolitholapaxy the disposable electrode in the working continuous flow scope was not cauterizing when activated. The knife and loop electrode were both used and neither were working properly. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6544350 |
| MDR Report Key | 6544350 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-27 |
| Date of Event | 2016-09-09 |
| Report Date | 2017-04-27 |
| Date Reported to FDA | 2017-04-27 |
| Date Reported to Mfgr | 2017-04-27 |
| Date Added to Maude | 2017-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KNIFE ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2017-05-04 |
| Lot Number | 51002651 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |