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

Model Number	8654.224
Medical Device Problem Codes	Arcing of Electrodes (2289); Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
This is a follow up report to add and/or correct information from initial submission.
Event or Problem Description
Follow up #1 - adding and/or updating information.Physician was remover bladder tumor with instrument and device, spark was visualized at proximal end of scope, closest to physician.Equipment and scope were changed and cutting loop replaced.

• Brand Name: WORKING ELEMENT PASSIVE MONO
• 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: 6771713
• Report Number: 1418479-2017-00017
• Device Sequence Number: 653496
• Product Code: FDC
• UDI-Device Identifier: 04055207018736
• UDI-Public: 04055207018736
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K980302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8654.224
• Device Catalogue Number: 8654.224
• Device Lot Number: 179D12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 91