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.
Additional Manufacturer Narrative
D1, full name: hf-resection electrode, roller, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs.This report was submitted by the importer under the importer's report number: 2429304-2023-00376 the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information, based on the legal manufacturer's final investigation.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely, that the reported event occurred, due to wear and tear.Additionally, the loop at the distal end of the electrode wears out, during use and may break, burn or melt.However, the subject device was not returned.And the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18247726
• Report Number: 9610773-2023-03460
• Device Sequence Number: 6600757
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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