MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE; A4832

Model Number	A4832
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 that five biopsy forceps were damaged all due to the fracture of the fixing pins of the forceps head during an unspecified procedure.The fixing pin of the forceps head fell into the patient's uterine cavity.The fallen part was retrieved.There were no reports of patient harm.The requested additional information from the customer is currently pending.This is report 4 of 5.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
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.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS, 7 FR., SEMIFLEXIBLE
• Common Device Name: A4832
• 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: 23852042
• Report Number: 9610773-2025-08368
• Device Sequence Number: 9958751
• Product Code: NWW
• UDI-Device Identifier: 04042761006958
• UDI-Public: 04042761006958
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: 510(K) EXEMP
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: A4832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown