MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AIR/WATER VALVE

Model Number	MAJ-1444
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.During inspection and testing, there was a scratch on the valve.No red thread-like object was found.The weak air and water supply was also not reproduced.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported that during reprocessing of the subject device following an endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs) procedure, a red thread approximately twenty centimeters in length came out from the tip of the device after it was washed.After the device was cleaned a second time, a piece approximately one centimeter long came out of the device.Testing of the substance that came out of the device found it was fibrin.The user noted the air and water supply were weak during the procedure.The user also stated the pre-use inspection consisted only of checking balloon inflation.Other pre-use and post-use inspection was not performed.The device was not cleaned at the bedside following the procedure.The device was brought to the washroom following the procedure and cleaned in the sink, brushed, and put in the washing machine.There was no effect on the patient due to the event.This report is for an air/water valve that was in use at the facility at the same time as the endoscope.The endoscope is being reported on the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 possible the damage of the subject device (a scratch on the valve) was related to the cause of the reported phenomenon.The event can be prevented by following chapter 3 preparation and inspection of the instructions for use which state: "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 (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama,; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15120218
• Report Number: 3002808148-2022-00388
• Device Sequence Number: 7323184
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GF-UCT260: OLYMPUS GASTROVIDEOSCOPE
• Patient Sex: Unknown