MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; CUTTING ELECTRODE MONO 24FR 12/30°

Model Number	46782435
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On april 24, 2023, richard wolf medical instruments corp.(rwmic) received a medwatch report # (b)(4) regarding a working element passive mono 12/30° part 8674225, batch # unknown.According to the received information, "while using the resectoscope.Apparent there was a fire on the hand piece to the resectoscope during a prostate procedure.No harm to the patient or surgeon during the event.The working element caught on fire during use." it is suspected that the cutting electrode mono 24fr 12/30°, part id: 46782435, batch # 21003532, within the hand piece (working element passive mono 12/30° part 8674225, batch # unknown) is what had ignited.The reported issue caused a 15 minute delay in the procedure while the fire was put out and the back-up device retrieved to complete the scheduled procedure.There is no report of injury to the patient or other personnel.

• Brand Name: SHARK
• Common Device Name: CUTTING ELECTRODE MONO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16989269
• Report Number: 9611102-2023-00029
• Device Sequence Number: 20526055
• Product Code: FAS
• UDI-Device Identifier: 04055207049051
• UDI-Public: 04055207049051
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K060720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2023

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: 46782435
• Device Catalogue Number: 46782435
• Device Lot Number: 21003532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART 815.053 - HF CONNECTION CABLE MONO L 5M; PART 8674225 - WORKING ELEMENT PASSIVE MONO 12/30°
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 100 KG