MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE; FLEXIBLE ENDOSCOPIC GRASPING FORCEPS, REUSABLE

Model Number	A4825
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the flexible endoscopic grasping forceps could not be opened.The issue occurred during preparation before use for a therapeutic procedure.The procedure was completed using the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Based on the results of the investigation, the root cause could not be identified.However, the cause for the broken connecting pin was very likely due to incorrect reprocessing.Furthermore, corrosion might weaken the material near the jaws, and it also increases the resistance during movement.This might cause a breakage of parts, for example of the connection pin.Regarding the corrosion, the following reasons can be possible: - an inappropriate cleaning agent is used.- the forceps are not completely dried.- moving parts are not lubricated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, SHARK TEETH, 5 FR., SEMIFLEXIBLE
• Common Device Name: FLEXIBLE ENDOSCOPIC GRASPING FORCEPS, REUSABLE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20009888
• Report Number: 9610773-2024-01978
• Device Sequence Number: 7257774
• Product Code: NWW
• UDI-Device Identifier: 04042761006880
• UDI-Public: 04042761006880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 510KEXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: A4825
• Device Lot Number: 237W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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