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

Model Number	46221313
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The tip of the bipolar electrode broke off of the device while inside the bladder.The tip was able to be retrieved.No injury to patient.

• 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: 20343222
• Report Number: 20343222
• Device Sequence Number: 8053529
• Product Code: FAS
• UDI-Device Identifier: 04055207049716
• UDI-Public: (01)04055207049716(11)230705(17)280630(10)21004487
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2024
• Report Date (Section F): 09/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 46221313
• Device Catalogue Number: 4622.1313
• Device Lot Number: 21004487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 09/09/2024