MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT SUCTION VALVE

Model Number	MAJ-207
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the suction valve was connected when the connecting tube should have been used.The issue occurred during reprocessing.There were no reports of infections or patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be due to an inappropriate reprocessing has been performed.The event can be detected/prevented by following the instructions for use (ifu) which state: a labeling review was performed and confirmed that neither an ifu of the endoscope (cyf-vha) nor a package insert of the reprocessor made by the external manufacture states to connect the maj-207.Each of the descriptions is as follows: -an ifu of the cyf-vha: it shows a maj-1234 or a maj-1516 as a cleaning tube compatible with the oer (olympus endoscope reprocessor/washer-disinfector).It also describes that for details concerning appropriate connectors/adaptors, refer to the instructions of the aer/wd manufacturer.Olympus will continue to monitor field performance for this device.

• Brand Name: SUCTION VALVE
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo 190-0 182; JA 190-0182
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT; 34-3 hirai, hinode-machi; nishitama-gun, tokyo
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19487961
• Report Number: 3003637092-2024-00101
• Device Sequence Number: 7024929
• Product Code: FAJ
• UDI-Device Identifier: 04953170063428
• UDI-Public: 04953170063428
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K993041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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-207
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: FLEXIBLE VIDEO CYSTOSCOPE (CYF-VH)
• Patient Sex: Unknown