BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE SHEAR

    MDR report key: 2945943 · Received January 28, 2013

    Report

    Report Number
    2945943
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 26, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS IS BEING TURNED IN AS A PT SAFETY CONCERN: RECEIVED A CALL FROM OPERATING ROOM DIRECTOR THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHEN THE SURGEON WENT TO USE AND ETHICON ENDO-SURGERY REPROCESSED HARMONIC ACE SHEARS FROM THAT IT WOULD LEAVE A FILM OR PLASTIC ADHERED TO THE INTERNAL TISSUE. OPERATING ROOM DIRECTOR STATED THAT SURGEON BELIEVED THEY REMOVED ALL OF THIS FOREIGN MATERIAL. UNABLE TO FIND ANY DOCUMENTATION AS TO VERIFY THIS. WE DID NOT HAVE THE PACKAGE WITH THE LOT NUMBER SO ALL REPROCESSED HARMONIC ACE DEVICES WERE PULLED OFF THE SHELF TILL WE COULD CLARIFY THE LOT NUMBER. ONLY HAD THE REPROCESS NUMBER SO THE STRYKER REP WAS CALLED AND UNABLE TO GIVE THE LOT NUMBER TILL THE FOLLOWING MONDAY (B)(6) /2013. ON (B)(6) 2013, THE STRYKER REP (B)(4) CALLED AND GAVE THE LOT NUMBER AND THEN THE OTHER LOT NUMBERS WERE RELEASED BACK TO OUR SUPPLY FOR USE. REPROCESS NUMBER ON DEVICE IS (B)(4) AND WAS GIVEN THE LOT NUMBER AS 1942027. A PICTURE OF WHAT THE BLUE MATERIAL LOOKS LIKE WILL BE ATTACHED. PT WENT HOME THE SAME DAY OF SURGERY. TWO DAYS AFTER THIS EVENT HAD SIMILAR EVENT WITH NON-REPROCESSED HARMONIC FOCUS FROM ORIGINAL MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37772 HARMONIC ACE SHEAR HARMONIC ACE SHEAR LFL STRYKER SUSTAINABILITY SOLUTIONS 1942027

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR