BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2772222 · Received October 2, 2012

    Report

    Report Number
    2134070-2012-00259
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    PMA / PMN Number
    K050343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE TEFLON PAD MISSING FROM THE TIP. THE DEVICE WAS FUNCTIONALLY TESTED AND PASSED ALL FUNCTIONAL TESTING. ONE CAUSE FOR THIS TYPE OF DAMAGE IS THAT THE CLAMP OF THE DEVICE MAY HAVE BEEN CLOSED AND THE INSTRUMENT ACTIVATED WITHOUT TISSUE PRESENT. CARE SHOULD BE TAKEN NOT TO APPLY PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM. THE INSTRUCTIONS FOR USE STATE TO KEEP THE CLAMP ARM OPEN WHEN BACKCUTTING OR WHILE THE BLADE IS ACTIVE WITHOUT TISSUE BETWEEN THE BLADE AND TISSUE PAD TO AVOID DAMAGE TO THE TISSUE PAD. THE RESULTING DAMAGE CONTRIBUTES TO THE REMOVAL OF THE PAD FROM THE CLAMP ARM. CLEANING OF THE PAD NOT IN ACCORDANCE WITH THE IFU CAN ALSO RESULT IN REMOVAL OF THE PAD DURING USE. AS THE TISSUE PAD WAS NOT RETURNED WITH THE DEVICE, IT COULD NOT BE DETERMINED WHAT CAUSED THE PAD TO FALL OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE BELIEVED TO BE A LAPAROSCOPIC CHOLECYSTECTOMY THE WHITE TISSUE PAD FELL OFF OF THE DEVICE. THE PAD WAS RETRIEVED WITH NO ISSUE. ANOTHER HARMONIC SCALPEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NLQ STERILMED, INC. ETHACE36E

    Patients

    Seq Age Sex Outcome Treatment
    1