BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT SWITCH

    MDR report key: 2873458 · Received November 15, 2012

    Report

    Report Number
    8010047-2012-00416
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K970797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2012-00416. OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED. THE CONCLUSION OF THIS ISSUE IS NO DIFFERENT FROM THE INITIAL REPORT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED USER'S REPORT. THE OUTPUT OF PSD-30 DID NOT STOP EVEN IF THE FOOT SWITCH PEDAL WAS RELEASED. THERE WERE CORROSION AND STAIN ON EXTERNAL SURFACE OF THE FOOT SWITCH. THE DEVICE WAS USED FOR MORE THAN 10 YRS. THIS PHENOMENON WAS ATTRIBUTED TO EXCESSIVE USAGES. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A HOT BIOPSY PROCEDURE, USERS EXPERIENCED FOOT SWITCH PEDAL OF PSD-30 COULD NOT BE RELEASED AND OUTPUT OF PSD-30 COULD NOT BE STOPPED. A POLYP WAS CUT AND A BIOPSY FORCEPS WAS WITHDRAWN FROM AN ENDOSCOPE. AFTER THAT, USERS TURNED OFF PSD-30 AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOT SWITCH FOOT SWITCH GEI OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-811 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR