BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2471560 · Received February 28, 2012

    Report

    Report Number
    1056128-2012-00020
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Report Date
    February 3, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NEVER RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED. SINCE FUNCTION TESTING COULD NOT BE PERFORMED, A ROOT CAUSE COULD NOT BE DETERMINED. COAGULATION EFFECTIVENESS IS RELATED TO VARIOUS FACTORS AMONGST THEM, BUT NOT LIMITED TO, POWER LEVEL AND SURGICAL TECHNIQUE. SSS 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 NUMEROUS FACTORS INCLUDING POWER LEVEL, BLADE CHARACTERISTICS, GRIP FORCE, TISSUE TENSION, TISSUE TYPE, PATHOLOGY, AND SURGICAL TECHNIQUE." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE INDICATED THE DEVICE PASSED ALL INSPECTIONS PRIOR TO RELEASE FROM SSS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR AN INVESTIGATION. HOWEVER, THE FACILITY STATED THEY WILL RELEASE THE DEVICE. ONCE THE DEVICE HAS BEEN RETURNED AND AN INVESTIGATION COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASONIC SCALPEL WAS NOT COAGULATING. A LIGACLIP DEVICE AND SUCTION WERE APPLIED TO CONTROL THE BLEEDING. THE DEVICE WAS REPLACED WITH ANOTHER SCALPEL. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLQ NLQ STRYKER SUSTAINABILITY SOLUTIONS ACE36E 1774555

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR