MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD; FLEXIBLE ENDOSCOPIC GRASPING FORECEPS, REUSABLE

Model Number	A2500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the tip of the subject device broke off and fell off outside the patient body during an unspecified therapeutic procedure.The procedure was completed with an olympus back-up device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, d9, h2, h3, h6 and h11.The device was returned to olympus for inspection, and the reported failure was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: the jaws at the tip had come off.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: this event was caused by a component failure.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 received from customer.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: g6, h2, h6, h11 in addition, the following reportable malfunctions were identified during the device evaluation: the jaws at the tip was damaged, so the jaws could not be opened or closed a root cause could not be identified.Based on the results of the investigation, the most probable cause for the malfunction is traced to component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, 5 FR., SEMI-FLEXIBLE, STANDARD
• Common Device Name: FLEXIBLE ENDOSCOPIC GRASPING FORECEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22948652
• Report Number: 9610773-2025-05561
• Device Sequence Number: 18275195
• Product Code: GCP
• UDI-Device Identifier: 04042761003483
• UDI-Public: 04042761003483
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2026

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: A2500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/21/2025; 12/10/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/16/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown