MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. SHARK; RESECTOSCOPE, WORKING ELEMENT

Model Number 8674225

Device Problem Fire (1245)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

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.

• Brand Name: SHARK
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy.; vernon hills IL 60061
• MDR Report Key: 16795204
• MDR Text Key: 313830647
• Report Number: 16795204
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2023

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: 8674225
• Device Catalogue Number: 8674225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Male
• Patient Weight: 100 KG