MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-210U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	09/04/2025
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 during a therapeutic colonoscopy, when disposable biopsy forceps were used bleeding occurred which required a clip.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and additional investigation details.Updated fields: b5, d8, g2, h2, h4.Corrected fields: d4.The device was not returned to olympus for inspection, and the reportable malfunction was not confirmed.Images provided by the customer were available and upon reviewing the images, confirmed bleeding had occurred from the tissue.A root cause could not be identified since the actual product was not sent to olympus and it was not possible to verify whether there was any abnormality with the product.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
Additional information was received from the customer, stating that the bleeding was a size of a bite, categorized as mild.The health care provider used a clip to stop the bleeding.There were no reports of further patient harm.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 23083963
• Report Number: 9614641-2025-01570
• Device Sequence Number: 11923505
• Product Code: FCL
• UDI-Device Identifier: 04953170031021
• UDI-Public: 04953170031021
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: N/A
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FB-210U
• Device Lot Number: 4YT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown