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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this point, the device is not going to be returned.However, the investigation is ongoing.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
It was reported, the single use adaptor biopsy valve began leaking and spraying water during a procedure.According to the initial reporter, the user covered the valve with a towel and they continued working.The procedure was successfully completed.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr) was conducted during this investigation.As the production lot number of the equipment is unknown, we checked the dhr for one year (january 2020 to december 2020) from the date of occurrence and found that there are no abnormalities in the inspection items related to the event reported.The root cause could not be determined.However, probable causes for the reported event may include: - the rubber of the biopsy valve is damaged or deformed by attaching/detaching the aspiration biopsy needle and the syringe during the procedure.- the biopsy valve was not placed properly on the endoscope.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 11-dec-2020.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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: 11407522
• Report Number: 8010047-2021-03264
• Device Sequence Number: 4503302
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/05/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/09/2021; 06/11/2021; 11/08/2022
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/17/2021; 06/11/2021; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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