MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-08-07 for WORKING ELEMENT PASSIVE MONO 8654.224 manufactured by Richard Wolf Medical Instruments Corp (rwmic).
[82066038]
Device returned to manufacturer for evaluation on 07/26/2017. The block, which locks in the electrode and where the hf cable is connected, was loose and moving out of position. Due to the block moving the electrode may have been misaligned or not inserted completely and arching/sparking occurred. Charring on the proximal end of the electrode supports this conclusion. In addition, the shaft of device was bent and heavily dented due to rough handling. Per instruction manual, "immediately before and after each use, check the products for damage, loose parts and completeness. Do not use the products if they are damaged or incomplete or have loose parts. " device is almost 6 years old and rwmic has no record of device being sent in for routine maintenance or repair since the purchase on (b)(6) 2013. Rwmic contacted initial reporter at the facility, via email, and requested medwatch missing information. No response as of 08/07/2017. Rwmic considers this matter closed, however, in the event additional information is received, rwmic will submit a follow-up report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[82066039]
Richard wolf medical instruments corporation (rwmic) was notified by a company representative that during a procedure a spark was seen. No illness / injury were report and there were no delays in the procedure which put the patient at risk. Back up device available for use and procedure was completed as scheduled. Initial reporter has been contacted, via email, in efforts to gather required medwatch information. Rwmic has not received a response as of 08/07/2017. Manufacture date: dec2012. Purchase date: (b)(6) 2013. Service dates: none on record.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2017-00017 |
| MDR Report Key | 6771713 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-08-07 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-07-11 |
| Date Mfgr Received | 2017-08-11 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2017-08-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DAWN CLARK |
| Manufacturer Street | REGISTRATION #1418479 353 CORPORATE 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 CORPORATE 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 | WORKING ELEMENT PASSIVE MONO |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2017-08-07 |
| Returned To Mfg | 2017-07-26 |
| Model Number | 8654.224 |
| Catalog Number | 8654.224 |
| 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 | REGISTRATION #1418479 353 CORPORATE WOODS PARKWAY VERNON HILLS IL 600613110 US 600613110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-07 |