MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIOPSY FORCEPS, 5 FR., SEMI-FLEXIBLE; A2499

Model Number	A2499
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a diagnostic left ureteroscopy for suspected urothelial neoplasm of the kidney, when closing the branches of the subject device during the second biopsy attempt the forceps were dislodged and the two branches remained with the ureteral lumen.With the aid of the zerotip basked, one of the two branches was retrieved.Several attempts to retrieve the second branch were unsuccessful due to the presence of clots and disease obliterating the ureteral lumen.Intraoperative fluoroscopic imaging was performed to confirm the presence of the retained branch.The procedure was completed, and the biopsy sample was obtained with the aid of a backup device.It was determined that no additional surgery was required at the time for removal of the retained piece as the patient was a candidate for nephroureterectomy procedure due to pathology and the fragment can be removed at that time.Unplanned antibiotic therapy was administered in the post-operative period to reduce the risk of infection.The patient was discharged after a few days of observation and scheduled for nephroureterectomy.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
Update to d9.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.

• Brand Name: BIOPSY FORCEPS, 5 FR., SEMI-FLEXIBLE
• Common Device Name: A2499
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22008483
• Report Number: 9610773-2025-03307
• Device Sequence Number: 7985293
• Product Code: GCP
• UDI-Device Identifier: 04042761003476
• UDI-Public: 04042761003476
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: A2499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PEREZ-ASTRO URETEROSCOPE.; ZEROTIP BASKET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown