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

Model Number	FB-240U
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Laceration(s) (1946); Gastrointestinal Hemorrhage (4476)
Date of Event	06/13/2025
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.This report is related to (b)(4).
Event or Problem Description
It was reported that during a cold biopsy procedure, while using disposable biopsy forceps, the device did not close properly.Another set of disposable biopsy forceps were obtained, and an adequate tissue sample was collected.The forceps tore the patient's mucosa, and a clip was required to close the tear and stop bleeding.The procedure was completed as planned.The patient was discharged and advised of the clip with instructions on identifying signs of bleeding.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: h6, h11.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.However, based on findings from similar past investigations, the factors causing the reported event might be the following: ·force the distal end of the insertion portion against body cavity tissue excessively ·the tissue was difficult to resect.·the shape and angle of the endoscope insertion section were tight.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information, and device evaluation based on the approved final investigation.Updated fields: d8, h3 and h6.The device was returned to olympus for inspection and the reported failure was not confirmed.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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: 22475295
• Report Number: 9614641-2025-01174
• Device Sequence Number: 8668829
• Product Code: FCL
• UDI-Device Identifier: 04953170354144
• UDI-Public: 04953170354144
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2025

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-240U
• Device Lot Number: 3XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 10/01/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/01/2025; 10/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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