MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ADAPTOR BIOPSY VALVE; SINGLE USE ADAPTER BIOPSY VALVE

Model Number	MAJ-1414
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the valve was leaking and spraying water during an unspecified therapeutic procedure.The leak happened before the valve was manipulated and prior to the needle or syringe being applied to the valve.The user covered the valve with a towel in order to finish the procedure.There was no effect on the patient due to the event.
Additional Manufacturer Narrative
The suspect device was not sent to olympus for evaluation.Therefore, the reported event and condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the valve leaking.There were no abnormalities in the inspection sheets.Based on the results of the legal manufacturer's investigation, it is likely the leak was due to the rubber of the biopsy valve being damaged or deformed by attaching and detaching the aspiration needle and the syringe during the procedure, or the biopsy valve was not placed properly on the endoscope.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted for additional information received after the initial report was submitted.H4: the device was manufactured in april 2019.The specific date of manufacturer could not be determined and april 1, 2019 was used in h4 of this report.

• Brand Name: SINGLE USE ADAPTOR BIOPSY VALVE
• Common Device Name: SINGLE USE ADAPTER BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14892545
• Report Number: 8010047-2022-11239
• Device Sequence Number: 5062775
• Product Code: PSV
• UDI-Device Identifier: 04953170181009
• UDI-Public: 04953170181009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2022

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: MAJ-1414
• Device Lot Number: 94K
• Was Device Available for Evaluation?: No
• 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: 12/11/2020
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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
• Patient Sex: Unknown