MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-01 for WORKING ELEMENT 8680.224 manufactured by Richard Wolf Medical Instruments Corp..
[5691112]
Richard wolf medical instruments corp (rwmic) received a (b)(4) event report indicating electrode sparked at distal end during procedure. Facility discontinued procedure and equipment removed. No injury to pt or staff was reported. Complaint log reviewed and complaint was submitted by reporting facility ((b)(6) 2014, no spark reported at this time) on two device types due to burn mark seen on one of the device types (electrode), they consist of the following: electrode (4630022) report #: 1418479-2014-00006; working element (8680. 224) report # 1418479-2014-00008. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13273305]
On (b)(6) 2014, facility reported a burn mark where the electrode meets the working element and both devices were sent to rwmic for investigation. Investigation revealed electrode and housing of the working element were both bent. In addition, the seal in the electrode holder (where electrode enters the working element) was damaged. These two findings indicate the most likely root cause of the issue is incorrect assembly (electrode inserted with out scope) or electrical source was set too high. Add'l info requested, no response as of 04/01/2015. Rwmic considers this matter closed. However, the event we receive add'l info, we will provide manufacturer with f/u info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2015-00008 |
| MDR Report Key | 4669114 |
| Report Source | 06 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-16 |
| Date of Event | 2015-09-15 |
| Date Mfgr Received | 2015-03-16 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2015-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAWN CLARK |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2015-04-01 |
| Returned To Mfg | 2014-10-27 |
| Model Number | 8680.224 |
| Catalog Number | 8680.224 |
| Lot Number | 65N07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-01 |