MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2015-10-08 for BIPOLAR WORKING ELEMENT 8680.224 manufactured by Richard Wolf Medical Instruments Corp (rwmic).
[27766899]
Investigation revealed device was missing screw and thumb ring. Device also had an electrical short. In addition, the device is over two years old and had never been submitted to rwmic for any repairs or routine maintenance. Manufacture date: 12/2012. Purchase date: (b)(6) 2013. Additional information requested concerning the event, no response as of 10/07/2015. Rwmic considers this matter closed. However, in the event we receive additional information, we will provide fda with follow-up information.
Patient Sequence No: 1, Text Type: N, H10
[27766900]
During a case the device became hot and doctor felt a shock. After case completed doctor noticed burn on finger.
Patient Sequence No: 1, Text Type: D, B5
[28869216]
User facility submitted additional information on 10/21/2015. Added patient information and initial reporter information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2015-00034 |
| MDR Report Key | 5135923 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-10-08 |
| Date of Report | 2015-10-21 |
| Date of Event | 2015-09-09 |
| Date Mfgr Received | 2015-10-21 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2015-10-08 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DAWN CLARK |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8003239653 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Street | 353 CORPORTATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOLAR WORKING ELEMENT |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2015-10-08 |
| Returned To Mfg | 2015-09-23 |
| Model Number | 8680.224 |
| Catalog Number | 8680.224 |
| Lot Number | 179D12 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) |
| Manufacturer Address | 353 CORPORTATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-08 |