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

Model Number 46782435

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Device not returned to manufacturer.

• Brand Name: SHARK
• Type of Device: CUTTING ELECTRODE MONO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16989026
• MDR Text Key: 315816568
• Report Number: 1418479-2023-00010
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207049051
• UDI-Public: 04055207049051
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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