BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3233796 · Received July 18, 2013

    Report

    Report Number
    0001056128-2013-00110
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    GEI
    PMA / PMN Number
    K012625
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. INSPECTION OF THE RETURNED DEVICE REVEALED A SPLIT IN THE INSULATION. FURTHER INSPECTION UNDER LIGHTED MAGNIFICATION REVEALED BURRS ON THE HINGE WHERE THE INSULATION SPLIT, WHICH IS AN INDICATION THAT AN INADVERTENT FORCE AGAINST ANOTHER SOLID/HARD OBJECT MAY HAVE OCCURRED DURING USE. POTENTIAL CAUSES FOR THE DAMAGED INSULATION CAN BE ATTRIBUTED BUT NOT LIMITED TO, OVER ACTIVATING THE INSTRUMENT, USING THE DEVICE WITH HIGHER SETTINGS THAN NEEDED TO REACH DESIRED TISSUE EFFECT, OR IN COMBINATION WITH INADVERTENT AND/OR EXCESSIVE FORCE AGAINST ANOTHER SOLID/HARD OBJECT DURING USE SUCH AS STAPLES, CLIPS, BONY SURFACE, TROCAR SURFACE, ETC. SSS'S INSTRUCTIONS FOR USE STATE: "TO AVOID DAMAGE TO PATIENT, TO OPERATOR OR INSTRUMENT, BECOME FAMILIAR WITH A SPECIFIC INSTRUMENT AND ITS CLAMPING OR CUTTING MECHANISM PRIOR TO EMPLOYING IT IN A SURGICAL PROCEDURE." "CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE AS A RESULT OF EXCESSIVE FORCE." "INSTRUMENTS WERE DESIGNED FOR CUTTING SOFT TISSUE. ATTEMPTING TO CUT STAPLES OR CLIPS MAY DAMAGE THE INSTRUMENT." "CLOSE BLADES OR JAWS BEFORE ATTEMPTING TO WITHDRAW INSTRUMENT THROUGH THE CANNULA. VISUALIZE FULLY TO AVOID TRAPPING TISSUE BETWEEN THE JAWS OF THE INSTRUMENT AND CAUSING INADVERTENT DAMAGE. PULL THE INSTRUMENT STRAIGHT OUT THOUGH THE CANNULA, AVOIDING LATERAL PRESSURE THAT MAY DAMAGE THE WORKING TIP." "SET THE VOLTAGE (POWER) AT THE LOWEST POSSIBLE SETTING THAT PROVIDES THE DESIRED SURGICAL EFFECT." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2011-00001 WHERE THE DEVICE BURNED THE PATIENT'S LIVER EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. 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 PROCEDURE THE INSULATION CAME OFF OF THE LAPAROSCOPIC SCISSORS. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335473 NA GEI GEI STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 5DCS 2476275

    Patients

    Seq Age Sex Outcome Treatment
    1