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

Model Number	FB-231D
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is linked to the following patient identifiers: (b)(6).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 diagnostic endobronchial ultrasound (ebus) procedure; while using the broncho videoscope along with a single-use biopsy valve, a piece of the biopsy valve fell off into the patient¿s body when the biopsy forceps were inserted into the scope and reached the distal end of the scope.After the procedure, inspection of the biopsy valve revealed that the seal ring inside the biopsy valve was chipped.It is suspected that the seal ring may have fallen into the patient¿s body.While attempting to retrieve the fallen object, the patient began coughing, and the object was lost from view.The fallen object was not retrieved.It was unclear whether the object remained in the lung or the stomach.According to the physician, it is likely that the object was expelled toward the stomach as a result of the coughing.A lung examination was performed, but the fallen object could not be found.Additional information was received confirming that diagnostic imaging was used and the patient was under sedation during the procedure.The procedure was completed using the same device with a delay of more than 30 minutes.There were no further reports of patient harm.
Event or Problem Description
No additional information received from 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.It is likely that the slit in the rubber valve or the area around the hole was damaged by overloading due to insertion and withdrawal of the biopsy forceps at an angle to the biopsy valve.Olympus will continue to monitor field performance for this device.

• 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: 22324205
• Report Number: 9614641-2025-01053
• Device Sequence Number: 8794126
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950636
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-231D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 08/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-P290 BRONCHOVIDEOSCOPE.; MAJ-210 SINGLE USE BIOPSY .
• Patient Sex: Unknown