MAUDE Adverse Event Report: AIR/WATER VALVE

Model Number	MAJ-1444
Medical Device Problem Codes	Material Deformation (2976); Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the endoscope (gf-uct260) made it impossible to send air.After the procedure, the customer confirmed found that a blood clot was generated from the duct of the endoscope.The reported problem was found during puncture suction method under ultrasound endoscopy.The procedure was completed using the same set of equipment without any problems by continuing the procedure.There was no harm or user injury reported due to the event.The customer reprocessing the device as instructed by olympus.
Additional Manufacturer Narrative
Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.The device is an air/water button used in combination with the endoscope of this reportable malfunction.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.Additionally, the repair center found the following.There was a damage on the packing part of the device.As a result of checking the operation of the equipment, no functional abnormalities were confirmed.The device history record was unable to be reviewed for this device since the 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, the root cause could not be determined.There was a possibility that this phenomenon is attributed to the damage of the device.The event can be detected/prevented by following the instructions for use which state: chapter 3 preparation and inspection-warning-using a valve that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.Olympus will continue to monitor field performance for this device.

• Brand Name: AIR/WATER VALVE
• Common Device Name: AIR/WATER VALVE
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15358908
• Report Number: 3002808148-2022-01709
• Device Sequence Number: 5227471
• Product Code: ODG
• UDI-Device Identifier: 04953170355929
• UDI-Public: 04953170355929
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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-1444
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 09/05/2022
• 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