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

Model Number 8680.224

Device Problems Unintended Power Up (1162); Grounding Malfunction (1271)

Patient Problems No Consequences Or Impact To Patient (2199); Lead(s), Burn(s) From (3161)

Event Date 05/30/2017

Event Type  malfunction  

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 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.

Event 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.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.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: dawn clark ; registration #1418479; 353 corporate woods parkway; vernon hills, IL 60061-3110 ; 8003239653
• MDR Report Key: 6675277
• MDR Text Key: 78908811
• Report Number: 1418479-2017-00014
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042946
• UDI-Public: 04055207042946
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other