MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-12-02 for WORKING ELEMENT 8680.224 manufactured by Richard Wolf Gmbh.
[16847896]
Richard wolf medical instrument corporation (rwmic) was notified by one of its sales representatives that during a bipolar turp procedure, one of the nurses touched the head of the pt and was shocked. Nurse reported losing hearing for a while. No injury to pt, was reported. Three possible suspect devices below were being used at the time of the incident, they consist of the following: bipolar cable (id# (b)(4)) report 1418479-2014-00049. Working element (id# (b)(4)) report 1418479-2014-00050. Generator (id# (b)(4)) report 1418479-2014-00051. Facility: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[17079335]
An investigation has not been completed, actual devices are in transit to the rwmic facility, rwmic will then send devices to manufacture for investigation. A request for additional info has been submitted to facility, no response as of 11/21/2014. Richard wolf medical instruments corporation considers this matter closed. However, in the event we receive additional info, we will provide manufacturer/fda with follow-up info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2014-00050 |
| MDR Report Key | 4321061 |
| Report Source | 99 |
| Date Received | 2014-12-02 |
| Date of Report | 2014-10-22 |
| Date Facility Aware | 2014-10-22 |
| Report Date | 2014-11-21 |
| Date Reported to FDA | 2014-11-21 |
| Date Reported to Mfgr | 2014-11-21 |
| Date Added to Maude | 2014-12-12 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2014-12-02 |
| Model Number | 8680.224 |
| Catalog Number | 8680.224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STRASSE 32 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-02 |