MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) WORKING ELEMENT

Model Number	8680.224
Medical Device Problem Codes	Unintended Power Up (1162); Grounding Malfunction (1271)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Lead(s), Burn(s) From (3161)
Date of Event	05/31/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (that may have been used two years ago) were also 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.Three similar event resulting in an mdr has occurred on this device in the last three years (mdr 1418479-2014-00050, 1418479-2017-00014 & 1418479-2017-00015).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, 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 times 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.
Event or Problem Description
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.Occured approximately two years ago.This event has occurred on three separate occasions: 1) (b)(6) 2017 - mdr 1418479-2017-00014.2) (b)(6) 2017 - mdr 1418479-2017-00015.3) (b)(6) 2015 - mdr 1418479-2017-00016.User facility contacted in an effort to gather additional/missing information, no response as of 06/28/17.List of rwmic items used during procedure: 1) working element (id #8680.224), 2) electrode (id #4622.1333).List of rwmic (b)(6) items used during procedure: 1) inner sheath (id #8655.3841), 2) outer sheath (id #8655.374), 3) connector (id #8654.3742).List of other known items used during procedure: 1) erbe vio generator (id #unknown), 2) erbe bipolar cable (id #8108.232), 3) ekg monitor (id #unknown).Suspect device at this time is the working element id #8680.224.

• Brand Name: WORKING ELEMENT
• Common Device Name: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 6675287
• Report Number: 1418479-2017-00016
• Device Sequence Number: 16637214
• Product Code: FDC
• UDI-Device Identifier: 04055207042946
• UDI-Public: 04055207042946
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8680.224
• Device Catalogue Number: 8680.224
• Device Lot Number: 65M08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other