BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2760146 · Received September 26, 2012

    Report

    Report Number
    1056128-2012-00104
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    August 30, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE LOT NUMBERS AND SERIAL NUMBERS WERE UNKNOWN ALONG WITH PROCEDURE DATE, DEVICE MANUFACTURE DATE AND EXPIRATION DATE. IT WAS REPORTED THAT BOTH DEVICES WERE USED IN THE SAME PROCEDURE AND BOTH EXPERIENCED "INTERMITTENT ACTIVATION." A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED AND THE FACILITY'S EQUIPMENT (THE HAND PIECE USED TO CONNECT THE INSTRUMENT TO THE GENERATOR AND THE GENERATOR ITSELF) COULD NOT BE EVALUATED. AS THE GENERATOR AD HAND PIECE WORK TOGETHER TO POWER THE INSTRUMENTS, ANY FAILURES OF THESE PIECES OF EQUIPMENT WILL RESULT IN THE INSTRUMENTS NOT WORKING PROPERLY. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, TWO ULTRASONIC SCALPELS EXPERIENCED "INTERMITTENT ACTIVATION." NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1