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

Model Number	MH-443
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of when placing finger on suction button a tiny drop of water touched the fingertip was not confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause could not be determined.No abnormality in the appearance was seen, and as a result of the operation check no abnormalities were confirmed.The instruction manual provides the following: ¿inspection of the suction function, 1 depress the suction valve and confirm that water is continuously aspirated into the suction bottle of the suction pump.2 release the suction valve.Confirm that suction stops and that the valve returns smoothly to its original position.3 depress the suction valve and aspirate water for one second.4 release the suction valve for one second.5 repeat step 3 and 4 several times and confirm that no water leaks from the biopsy valve.6 remove the distal end of the endoscope from the water.Depress the suction valve and aspirate air for a few seconds to remove any water from the instrument channel and suction channel.¿ olympus will continue to monitor field performance for this device.
Event or Problem Description
An olympus employee reported on behalf of a customer since around may, when the doctor puts his finger on the suction button (suction valve) he feels discomfort when water droplets touch his fingertip.The device was not wet from the surroundings but from where the finger was placed.It is speculated that water seeps out from the gap between the red dot and the black part of the device.The event occurred during a diagnostic colonoscopy.There was no report of patient harm associated with this event.The customer uses kaigen wm-s, disinfection with functional water during device reprocessing.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17336315
• Report Number: 9610595-2023-10217
• Device Sequence Number: 20736392
• Product Code: FDS
• UDI-Device Identifier: 04953170071256
• UDI-Public: 04953170071256
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2023

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: MH-443
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/17/2023
• 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: PCF-H190DI (2331134)
• Patient Sex: Unknown