BEUDAMED
    FDA Adverse Event Other Summary report: N

    VALLEYLAB HANDLE

    MDR report key: 824759 · Received March 8, 2007

    Report

    Report Number
    1530493-2007-00007
    Event Type
    Other
    Date Received
    March 8, 2007
    Date of Event
    October 4, 2006
    Report Date
    March 7, 2007
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K885200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND TESTED BY OUR ENGINEERING DEPARTMENT. THIS REUSABLE DEVICE IS WARRANTED FOR UP TO 20 USES OR 1 YEAR, WHICHEVER COMES FIRST. ENGINEERING DETERMINED THE DEVICE HAS BEEN THROUGH MULTIPLE USES IN EXCESS OF 20 TIMES. THE CABLE WAS CHECKED FOR CONTINUITY AND THE TEST INDICATED A BREAK ON THE CONDUCTOR. NO LEAKAGE WAS FOUND AND IT PASSED THE FIVE MINUTES SOAK TEST. THE PRODUCT IFU ADVISES THE USER TO INSPECT CABLE FOR BREAKS AND SIMILAR DAMAGE BEFORE EACH USE. THIS PRODUCT HAS OBVIOUSLY GONE PAST ITS NORMAL LIFECYCLE AND REQUIRES REPLACEMENT. THE ROOT CAUSE OF THIS INCIDENT IS EXTENDED USE OF PRODUCT BEYOND ITS LIFECYCLE AND FAILURE TO FOLLOW THE INSTRUCTION FOR USE ABOUT INSPECTION OF DEVICES BEFORE USE.

    Description of Event or Problem · 1

    OUR CUSTOMER REPORTED THIS INCIDENT TO OLSEN MEDICAL ON 2/13/2007. THE CUSTOMER TELEPHONED TO SAY THAT THEY HAD A RETURN FOR A DEVICE THAT SUPPOSEDLY CAUSED A BURN TO A PATIENT. WHEN THE DEVICE WAS RETURNED, THE ACCOMPANYING INFORMATION DESCRIBED THE EVENT. THE INCIDENT SAYS, "A PATIENT WAS BURNED (3RD DEGREE) ON THE SHOULDER; TWO BURN LINES OF RESPECTIVELY 5 AND 7 CM FOLLOWING CONTACT WITH THE DEVICE CABLE; THE DEVICE WAS CONNECTED TO THE FORCE FX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEYLAB HANDLE REUSABLE MONOPOLAR PENCIL GEI OLSEN MEDICAL 65002 117852

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other
    2
    3