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

Model Number	A4827
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the teeth on graspers (grasping forcep) broke.The issue occurred in the middle of a diagnostic hysteroscopy intrauterine device removal procedure.The procedure was completed using the similar device, with no delay.There were no reports of patient harm.
Additional Manufacturer Narrative
Device was not returned for evaluation and could not be evaluated.Based on the results of the investigation, the exact cause of the reported issue could not be determined.However, it is possible, that the application of excessive force, during use is the cause of the reported issue.A definitive root cause could not be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: GRASPING FORCEPS, MOUSE TOOTH, 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20614602
• Report Number: 9610773-2024-02652
• Device Sequence Number: 18005589
• Product Code: NWW
• UDI-Device Identifier: 04042761006903
• UDI-Public: 04042761006903
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: A4827
• Device Lot Number: UNKNOWN
• 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: 10/08/2024
• Initial Report FDA Received Date: 11/05/2024
• 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