BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE SUCTION VALVE (STERILE)

    MDR report key: 8702880 · Received June 17, 2019

    Report

    Report Number
    8010047-2019-02201
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    July 16, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    14953170152426
    PMA / PMN Number
    K061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED. THE BREAKAGE FOUND AT THE PROXIMAL END OF THE SUCTION CONNECTOR. THE MANUFACTURING PROCESS AND A MOLDING SUPPLIER FOR THE SUBJECT PRODUCT WERE CHANGED. AFTER THESE CHANGES, THE COMPLAINTS OF THE SUCTION VALVE BREAKAGE HAS BEEN RAISING. OMSC ASSUMES THAT THE CAUSE OF THE DAMAGE TO THE PRODUCT IS THAT AN UNEXPECTED LARGE LOAD WAS APPLIED TO THE SUCTION CONNECTOR. BOTH "PRODUCT BEFORE CHANGES" AND "PRODUCT AFTER CHANGES" MEET THE PRODUCT SPECIFICATION FOR DURABILITY. HOWEVER, WHEN AN UNEXPECTED LARGE LOAD WAS APPLIED TO THE SUCTION CONNECTOR, OMSC CONFIRMED THAT THE PRODUCT BEFORE CHANGES DOES NOT BREAK, BUT THE PRODUCT AFTER CHANGES MAY BREAK. OMSC MADE THE DECISION TO RE-PRODUCE THE PRODUCT WHICH BEFORE CHANGES. THE INSTRUCTION MANUAL OF THE PRODUCT HAS ALREADY WARNED AS FOLLOWS; ATTACHING THE SUCTION VALVE TO THE ENDOSCOPE: PRESS DOWN ON THE SUCTION VALVE'S TOP SURFACE WITH YOUR BOTH THUMBS UNTIL IT "CLICKS" INTO PLACE. INSPECTION OF OPERATION. PLACE THE DISTAL END OF THE INSERTION TUBE IN STERILE WATER AND DEPRESS THE SUCTION VALVE. CONFIRM THAT WATER IS CONTINUOUSLY ASPIRATED INTO THE SUCTION BOTTLE OF THE SUCTION PUMP. REMOVING THE SUCTION VALVE FROM THE ENDOSCOPE: ROTATE THE SUCTION CONNECTOR CLOCKWISE WITH YOUR THUMB.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY, THE SUBJECT DEVICE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUCTION CONNECTOR OF THE DEVICE BROKE OFF WHEN THE USER REMOVED THE DEVICE AFTER THE PROCEDURE. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE SUCTION CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496485 SINGLE USE SUCTION VALVE (STERILE) SINGLE USE SUCTION VALVE EOQ OLYMPUS MEDICAL SYSTEMS CORP. MAJ-209 14953170152426

    Patients

    Seq Age Sex Outcome Treatment
    1