BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2440109 · Received February 6, 2012

    Report

    Report Number
    1056128-2012-00008
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 12, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) SO DEVICE TESTING COULD NOT BE PERFORMED. THE DEVICE PACKAGING ALSO WAS NOT RETURNED SO INFORMATION SUCH AS LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE WERE NOT AVAILABLE. COAGULATION EFFECTIVENESS IS RELATED TO VARIOUS FACTORS INCLUDING, BUT NOT LIMITED TO, POWER LEVEL AND SURGICAL TECHNIQUE. SSS'S INSTRUCTIONS FOR USE STATE: "USE A HIGHER POWER LEVEL FOR GREATER TISSUE CUTTING SPEED AND A LOWER POWER LEVEL FOR GREATER COAGULATION. THE AMOUNT OF ENERGY DELIVERED TO THE TISSUE PAD AND RESULTANT TISSUE EFFECTS ARE A FUNCTION OF NUMBER FACTORS INCLUDING POWER LEVEL, BLADE CHARACTERISTICS, GRIP FORCE, TISSUE TENSION, TISSUE TYPE, PATHOLOGY, AND SURGICAL TECHNIQUE." SINCE THE COMPLAINT DEVICE COULD NOT BE FUNCTION TESTED, A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, HISTORICAL COMPLAINTS RELATED TO INADEQUATE COAGULATION WERE FOUND TO BE A RESULT OF GENERATOR SETTINGS AND/OR END USER TECHNIQUE. 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, THE ULTRASONIC SCALPEL "DID NOT CAUTERIZE PROPERLY" WHICH CAUSED "EXCESS BLEEDING." IT WAS REPORTED THAT THE PATIENT LOST AN ESTIMATE OF 100CC OF BLOOD, HOWEVER, THERE WAS NO PATIENT INJURY REPORTED OR MEDICAL INTERVENTION NEEDED.

    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