BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT SWITCH FOR UES - 40 MAJ-1258

    MDR report key: 5222194 · Received November 13, 2015

    Report

    Report Number
    8010047-2015-01059
    Event Type
    Malfunction
    Date Received
    November 13, 2015
    Date of Event
    October 5, 2015
    Report Date
    January 19, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS COOPERATION
    Product Code
    GEI
    PMA / PMN Number
    K063786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR INVESTIGATION. OLYMPUS IS INVESTIGATING THE SUBJECT DEVICE TO DETERMINE THE CAUSE OF THIS PHENOMENON. OLYMPUS ALSO CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, AND THERE WAS NO IRREGULARITY FOUND. OLYMPUS WILL SUBMIT A SUPPLEMENTAL MDR REPORT AFTER THE CAUSE OF THIS PHENOMENON IS DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2015-01059. OLYMPUS CONDUCTED DOCUMENT REVIEW OF THIS EVENT ON JANUARY 14, 2016. OLYMPUS NOTICED THE DATE FOR THE INITIAL REPORT WAS NOT OCTOBER 23, 2015 BUT OCTOBER 14, 2015. SO IT IS CORRECTED TO OCTOBER 14, 2015.

    Additional Manufacturer Narrative · 1

    THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT #8010047-2015-01059 TO PROVIDE DEVICE EVALUATION RESULTS. OLYMPUS PERFORMED FURTHER INVESTIGATION FOR THE SUBJECT DEVICE. OLYMPUS CONFIRMED THE SUBJECT DEVICE WORKED PROPERLY, BUT THE SUBJECT DEVICE RECORDED THE OUTPUT SWITCH ERROR SEVERAL TIMES. OLYMPUS CHECKED THE FOOT SWITCH ((B)(4)) WHICH WAS RETURNED WITH THE SUBJECT DEVICE AT THE SAME TIME, AND THERE WAS A TRACE OF CHEMICAL LIQUID AROUND THE FOOT SWITCH PEDAL. THE TRACE OF CHEMICAL LIQUID AROUND THE FOOT SWITCH PEDAL INDICATED THAT THE CHEMICAL LIQUID MIGHT FLOW INTO THE FOOT SWITCH PEDAL. THEREFORE, THE FOOT SWITCH MIGHT NOT WORK TEMPORARILY BECAUSE CONTACT FAILURE OF THE FOOT SWITCH PEDAL OCCURRED BY THE CHEMICAL LIQUID. ACCORDING TO THE INVESTIGATION RESULT, OLYMPUS DETERMINED THE CAUSE OF THIS PHENOMENON WAS RELATED TO FOOT SWITCH MALFUNCTION. THE INSTRUCTION MANUAL OF UES-40 ALREADY MENTIONS CAUTIONS FOR THE FOOT SWITCH HANDLING. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. 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 A MALFUNCTION OCCURRED IN THE SUBJECT DEVICE IMMEDIATELY AFTER THE FACILITY STARTED CHOLECYSTECTOMY. THE FACILITY COMPLETED THE PROCEDURE AFTER REPLACING THE SUBJECT DEVICE TO ANOTHER DEVICE. THERE WAS NO ACUTE BLEEDING FROM THE PATIENT IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751610 FOOT SWITCH FOR UES - 40 MAJ-1258 FOOT SWITCH GEI OLYMPUS MEDICAL SYSTEMS COOPERATION MAJ-1258

    Patients

    Seq Age Sex Outcome Treatment
    1