MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BIOPSY VALVE

Model Number	MB-358
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	01/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a bronchoscopy procedure, after the biopsies were completed, a fragment of the biopsy valve fell off into the patient's bronchus.The broken fragment was successfully retrieved using a grasping forceps.The procedure was delayed but the exact time was unknown; it was thought to be less than 30 minutes.There were no further reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d10, h3, h6.The device was returned to olympus for inspection and the reported failure was confirmed.It was confirmed that cap (hole) of biopsy valve was damaged and that the fallen piece fit the damaged cap of the biopsy valve.Further, the model mb-358 biopsy valve was used for bf-p290 videoscope which is incompatible (misuse).A definitive root cause could not be identified.Based on the results of the investigation, it is likely the valve damage was caused by impact being applied by forcibly inserting forceps or inserting it suddenly while the cap was on.The event can be detected/prevented by following the instructions for use: bf-p290* ifu operation manual ¿chapter 3 preparation and inspection 3.4 inspection of accessories_3.5 attaching accessories to the endoscope_3.8 inspection of the endoscopic system¿.¿chapter 4 operation: 4.3 using endotherapy accessories¿.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was received from the customer.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21294146
• Report Number: 9610595-2025-01052
• Device Sequence Number: 18038753
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: MB-358
• Device Lot Number: 119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown