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

Model Number	MB-358
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation but has not yet been received.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The olympus representative reported on behalf of the customer that during upper endoscopy, when a syringe was attached to the lid of the semi-disposable forceps plug, and liquid was delivered, part of the lid of the forceps plug was damaged and fell into the body.The damaged lid was recovered and there was no health hazard to the patient.
Event or Problem Description
Additional information received: the liquid sent when the problem occurred was "minclear internal spray liquid." it is a drug that comes in a syringe-like container.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to the initial with information inadvertently left out (b)(4) and to provide a correction to the initial (d9, d10, and h3).The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: a part of the cap section of the biopsy valve was recognized to be broken.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the syringe was forcibly or strongly inserted into the slit of the biopsy valve, which caused excessive external load to be applied and led to a tear.Therefore, a torn part of the cap could have fallen in the patient¿s body.However, the root cause of the suggested event could not be determined.The event can be detected/prevented by following the instructions for use which state: - air/water feeding and suction - feeding liquid through the instrument channel "when using a syringe to inject liquid through the biopsy valve, insert the syringe straight into the biopsy valve.Otherwise, patient fluids and/or debris may leak or spray from the biopsy valve, and it may cause an infection control risk." "when using a syringe to inject liquid through the biopsy valve, detach the valve¿s cap from the main body.Then insert the syringe into the valve.Otherwise, the biopsy valve could be damaged, and the syringe could be detached from the valve.Also, patient fluids and/or debris may leak or spray from the biopsy valve, and it may cause an infection control risk." olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17990959
• Report Number: 9610595-2023-15695
• Device Sequence Number: 18184301
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: MB-358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/13/2023
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H190 / SN: (B)(6), GIF-H190/ SN: (B)(6); SYRINGE WITH MINCLEAR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown