BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2802806 · Received October 24, 2012

    Report

    Report Number
    3005075853-2012-04848
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED WITH AN ECR60D UNFIRED LOADED IN THE DEVICE. FURTHER EVALUATION OF THE RELOAD FOUND THAT THE SLED WAS MISSING MAKING IT NON FUNCTIONAL. IT SHOULD BE NOTED THAT EACH CARTRIDGE RELOAD IS 100% INSPECTED THROUGH AN AUTOMATED VISION SYSTEM TO ENSURE THAT THE ONE PIECE SLED IS PRESENT PRIOR TO SHIPMENT. IN ADDITION, THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. THE DEVICE WAS DISASSEMBLED TO RESET THE BAILOUT SYSTEM AND THEN, IT WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. UPON FURTHER INSPECTION THE JOINT COVER WAS NOTED TO BE TORN; THERE IS NO EVIDENCE THAT THERE IS ANY PORTION OF THE JOINT COVER MISSING. IT IS POSSIBLE THAT THE DEVICE WAS ATTENDED TO BE PULLED OUT FROM A TROCAR IN THE ARTICULATED POSITION, RESULTING IN THE EDGE OF THE TROCAR DAMAGING THE JOINT COVER. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC GASTRIC SLEEVE PROCEDURE, THE DEVICE WAS CLOSED ON TISSUE AND FIRED, HOWEVER IT ONLY MADE A QUICK POWER SOUND BEFORE SHUTTING OFF. THE BLADE DID NOT ADVANCE AND NO STAPLES WERE DEPLOYED. THE DEVICE THEN WOULD NOT OPEN AND THE EMERGENCY RELEASE DID NOT WORK. THE SURGEON THEN YANKED THE DEVICE OFF OF TISSUE AND IT WAS REPORTED THAT ONLY THE SPECIMEN SIDE OF THE TISSUE TORE AND THEREFORE, NO PATIENT INJURY WAS REPORTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C776

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G