BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUT&COAG ACC, LAP & ENDO REPRCSSD

    MDR report key: 6195307 · Received December 21, 2016

    Report

    Report Number
    2134070-2016-00091
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 28, 2016
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K012598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A SUPPLEMENTAL FORM WILL BE SENT ONCE THE EVALUATION IS COMPLETED IF THE DEVICE IS RETURNED. THE DEVICE HISTORY REPORT WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS EVALUATED AND HEAVY CONTAMINANTS WERE FOUND TO BE PRESENT. THE DEVICE WAS ABLE TO BE OPENED WITH EFFORT AND PROCEEDED TO PASS ALL FUNCTIONAL TESTING ONCE OPENED. THE DEVICE'S FUNCTIONALITY WAS LIKELY AFFECTED BY THE HEAVY CONTAMINANTS WHEN THE DEVICE WAS NOT PROPERLY CLEANED DURING USE AS DIRECTED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE CLAMPED ON THE PATIENT'S TISSUE AND WOULD NOT OPEN IT'S JAWS. IT WAS REPORTED THAT THE SURGEON HAD TO TEAR TISSUE TO FREE THE DEVICE. AFTER CORRESPONDENCE ASKING FOR ADDITIONAL INFORMATION, IT WAS REPORTED THAT THERE WAS NO SUBSTANTIAL BLOOD LOSS, JUST THE TORN TISSUE TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845839 CUT&COAG ACC, LAP & ENDO REPRCSSD NUJ STERILMED, INC. COVLF4318 1961673

    Patients

    Seq Age Sex Outcome Treatment
    1