MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	46222513
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As soon as the current was applied, the device popped and broke.Once this happened, no longer able to use the resectoscope after this event occurred.The scope was taken out of service and sent to sterile processing department for repairs.

• Brand Name: SHARK/S-LINE
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): RICHARD WOLF GMBH; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 19078527
• Report Number: 19078527
• Device Sequence Number: 15058946
• Product Code: FAS
• UDI-Device Identifier: 04055207050026
• UDI-Public: (01)04055207050026
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2023
• Report Date (Section F): 03/19/2024

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 Model Number: 46222513
• Device Catalogue Number: 4622.2513
• Device Lot Number: 4500356209
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White
• Date Report Sent to FDA: 03/19/2024