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

Model Number	MB-358
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
It was reported that when a physician passed the biopsy forceps through the slit of the biopsy valve forceps plug a large hole was made in the slit of the lid section.The issue was found during a diagnostic upper gastrointestinal endoscopy procedure.The intended procedure was completed using the same set of equipment.There were no reports of delays.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device history record was unable to be reviewed for this device since the serial 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 event occurred due to user handling of the product.The event can be prevented by following the instructions for use (ifu) which state in operation manual of an endoscope 'chapter 4 operation, 4.3 using endotherapy accessories': "please insert the product slowly when inserting it." 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: 18597207
• Report Number: 9610595-2024-01852
• Device Sequence Number: 8182730
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MB-358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/13/2024
• 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
• Patient Sex: Unknown