MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; WORKING ELEMENT PASSIVE MONO

Model Number	8674225
Medical Device Problem Codes	Break (1069); Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report with additional information and investigation of this complaint.
Event or Problem Description
On october 5th , 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the loops were completely burning out and breaking during a turp- we went through 5 different loops in one case, and it ended up charring the end of the sheath, which led to bits of metal breaking off into the patients body.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? (only applicable if there was a report of delay) unknown.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

• Brand Name: SHARK
• Common Device Name: WORKING ELEMENT PASSIVE MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10755385
• Report Number: 1418479-2020-00265
• Device Sequence Number: 1125709
• Product Code: FDC
• UDI-Device Identifier: 04055207056714
• UDI-Public: 04055207056714
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/05/2020

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: Health Professional
• Device Model Number: 8674225
• Device Catalogue Number: 8674225
• Device Lot Number: 1447623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1