BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUSABLE BIPOLAR CABLE, NON STERILE

    MDR report key: 1981252 · Received February 2, 2011

    Report

    Report Number
    1530493-2011-00001
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 2, 2011
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K953889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO OLSEN MEDICAL FROM (B)(6). THIS DEVICE WAS INSPECTED BY OUR ENGINEERING DEPARTMENT AND FOUND THE SPRING BANANA PLUG HAD COLLAPSED. THIS REUSABLE DEVICE IS OVER 1 YEAR OLD AND OLSEN MEDICAL ATTRIBUTES THIS INCIDENT TO USING THE DEVICE BEYOND IT'S LIFE CYCLE. PREVIOUS DOCUMENTATION STATES END-USER'S MAY USE THIS DEVICE 20 USES PER MONTH AND THE DEVICE IS ONLY WARRANTED FOR 20 USES. THE END-USER PROVIDED NO DATA AS TO HOW MANY TIMES THE DEVICE HAD BEEN USED. AGAIN, THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    A RN WAS ATTEMPTING TO INSERT A REUSABLE BIPOLAR CABLE INTO THE GENERATOR AND NOTICED IT HAD A LOOSE FIT. THE NURSE FURTHER TRIED TO HOLD THE GENERATOR PLUG IN PLACE DURING USE OF THE DEVICE AND GOT SHOCKED. NURSE IS REPORTEDLY FINE WITH NO FURTHER COMPLICATIONS. EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE BIPOLAR CABLE, NON STERILE REUSABLE BIPOLAR CABLE, GOLD PROBE ADAPT GEI OLSEN MEDICAL 87701 014978

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other