MAUDE Adverse Event Report: OLYMPUS WINTER IBE GMBH OLYMPUS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	WA22606S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While resecting prostate during a transurethral resection prostate surgery the loop electrode got caught while in the patient on a urolift clip and the loop broke into 2 pieces both pieces.No harm to patient.

• Brand Name: OLYMPUS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): OLYMPUS WINTER IBE GMBH; 800 west park drive; westborough MA 01581
• MDR Report Key: 16351089
• Report Number: 16351089
• Device Sequence Number: 6299962
• Product Code: FAS
• UDI-Device Identifier: 14042761085158
• UDI-Public: (01)14042761085158
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/18/2023
• Report Date (Section F): 01/18/2023

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: WA22606S
• Device Catalogue Number: WA22606S
• Device Lot Number: 100102362
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/18/2023