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 2017-06-28 for WORKING ELEMENT 8680.224 manufactured by Richard Wolf Medical Instruments Corp (rwmic).
[78908811]
Richard wolf medical instruments (rwmic) received actual device from user facility on 06/20/2017. A visual inspection of device found device found charring around hf connector, where hf is connected to device. In addition, a few of the hf bipolar cables returned for evaluation also had some charring on the grey cable, cable which gets connected to neutral pin. These two finding indicate the most likely root cause of the issue is the bipolar cable ends were most likely not completely pressed down into position on the working element allowing electricity to flow through patient and up to staff member. Charring was also found on shaft of device indicating high voltage being used. No problems found when functional testing was performed on device. Instructions for use (ifu) has a caution statement: caution! Danger of burns! Inadvertent disconnection of the plug-and-socket connections and contact of the latter with bare metal parts, e. G. The operating table, holding arms etc. During hf applications can cause skin burns of the patient or user. Check the cable plugs and device plug for secure connection, replace the hf bipolar connection cable, if necessary. Request sent to user facility for additional/missing information requested, no response as of 06/28/2017. One similar event resulting in an mdr has occurred on this device in the last three years (mdr 1418479-2014-00050). Manufacturer date: 05/01/2008. Purchase date: 07/15/2008 (4 devices). Service dates: 01/08/2009, 01/08/2009, 05/13/2009 06/28/2010, 09/16/2010, 12/29/2010, 07/20/2011, 05/24/2012, 08/13/2012, 09/05/2012, 10/22/2013,12/03/2013, 09/29/2014, 11/18/2015, 03/03/2016, and 11/17/2016. Due to four device with the same lot #, unable to determine the number of time each device was submitted for service only that service was performed a total of sixteen in the last 9 years. Rwmic considers this matter closed. However, in the event rwmic receives additional information, follow-up report will be submitted to fda.
Patient Sequence No: 1, Text Type: N, H10
[78908812]
Richard wolf medical instruments corporation (rwmic) was notified by user facility that during a procedure the anesthesiologist touched an ekg electrode and was burned on the finger. No injury to the patient was reported. This event has occurred on three separate occasions: (b)(6). User facility contacted in an effort to gather additional/missing information, no response as of 06/23/2017. List of rwmic items used during procedure: working element (id #8680. 224). Electrode (id #4622. 1333). List of rwmic (b)(4) items used during procedure: inner sheath (id #8655. 3841). Outer sheath (id #8655. 374). Connector (id #8654. 3742). List of other known items used during procedure: erbe vio generator (id #unknown). Erbe bipolar cable (id #8108. 232). Ekg monitor (id #unknown). Suspect device at this time is the working element id #8680. 224.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2017-00014 |
| MDR Report Key | 6675277 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-30 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2017-06-28 |
| 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 |
| Generic Name | WORKING ELEMENT |
| Product Code | FDC |
| Date Received | 2017-06-28 |
| Returned To Mfg | 2017-06-20 |
| Model Number | 8680.224 |
| Catalog Number | 8680.224 |
| Lot Number | 65M08 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 1. Other | 2017-06-28 |