BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3120554 · Received May 20, 2013

    Report

    Report Number
    3005075853-2013-02425
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NICKED KNIFE, PREMATURE SLED MOVEMENT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? HOW WAS THE CASE COMPLETED? WHAT IS THE CURRENT STATUS OF THE PATIENT? THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED WITHOUT CARTRIDGE RELOAD, THE ANVIL WAS BENT UPWARDS AND BAILOUT DOOR MISSING, THE OVERRIDE LEVER WAS UP WHICH DENOTES THAT THE KNIFE WAS MANUALLY RETURNED TO HOME POSITION. PLEASE NOTE IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE TO HOME POSITION. TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE SYSTEM IS USED THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE FOUND CONDITION OF THE ANVIL MAY LEAD THAT THE MOST DISTAL STAPLES NOT TO FORM PROPERLY. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. FURTHER ANALYSIS FOUND THE CLAMPING MECHANISM DAMAGED. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS, THE DEVICE WAS DISASSEMBLED. UPON DISASSEMBLING, THE CLAMP ARM WAS NOTED TO BE WORN OUT, IT APPEARS THAT THE DEVICE WAS FORCED OPEN WHEN THE KNIFE NOT IN THE HOME POSITION. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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 VATS LOBECTOMY PROCEDURE, THE DEVICE WAS CAUGHT, CLAMPED DOWN ON THE ROBOTIC DEVICE AND THE JAWS WOULD NOT OPEN. THE SALES REPRESENTATIVE WALKED THEM THROUGH THE REVERSE BLADE FUNCTION AND MANUAL OVER-RIDE AND THE DEVICE JAWS WOULD NOT OPEN. THE JAWS WERE EVENTUALLY OPENED USING THE MANUAL OVER RIDE MULTIPLE TIMES. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221356 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1