MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTRODE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number	A22251C
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of the customer, reported to olympus that during a transurethral resection of the prostate, the monopolar rollerball of the hf-resection electrode broke off in patient.Despite multiple attempts to obtain additional information regarding the device and event, none was obtained.D1, full name of device: hf-resection electrode, roller, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs.

• Brand Name: ELECTRODE
• Common Device Name: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 18247565
• Report Number: 2429304-2023-00376
• Device Sequence Number: 7060241
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023
• Report Date (Section F): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A22251C
• Device Lot Number: 1000085722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/03/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male