BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3181594 · Received June 21, 2013

    Report

    Report Number
    3005075853-2013-03180
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED CARTRIDGE, DAMAGED DRIVERS, DAMAGED ONE PIECE SLED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? THE ISSUE HAPPENED ON THE SECOND FIRE. JUST FOR CLARIFICATION, WERE THE STAPLES MALFORMED? YES. WAS THE STAPLE LINE INCOMPLETE (FULLY CUT, BUT SOME STAPLES WERE MISSING)? NO. IF BUTTRESSING MATERIAL WAS UTILIZED, WHICH PRODUCT WAS USED? BUTTRESSING WAS NOT USED. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? NO. THE ANALYSIS FOUND THAT ONE CARTRIDGE WAS RECEIVED FOR ANALYSIS. UPON EVALUATION OF THE CARTRIDGE, IT WAS NOTED TO HAVE THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND TWO INNER ROWS PARTIALLY FIRED. IN ADDITION, THE RETURNED RELOAD WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. 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 REDO LAPAROSCOPIC SLEEVE PROCEDURE, THE GREEN RELOAD WAS PLACED INTO THE CARTRIDGE HALF OF THE POWERED ECHELON 60 AND PLACED OVER THE TISSUE THEN CLOSING TRIGGER WAS APPLIED. SURGEON DETERMINED THAT THE TISSUE WAS TOO THICK FOR THE RELOAD SO HE OPENED THE JAWS AND REMOVED THE GREEN RELOAD AND FIRED A BLACK RELOAD. HE SAID THE BLACK STAPLE LINE WAS PERFECT. HE PROCEEDED TO PLACE THE GREEN RELOAD BACK INTO THE CARTRIDGE HALF AND FIRE OVER THE FUNDUS OF THE STOMACH. HE NOTICED THERE WAS SOME AUDIBLE AND PALPABLE FEEDBACK WHEN FIRING AND ONCE HE COMPLETED THE FIRING SEQUENCE HE OPENED THE JAWS TO FIND THAT THE FIRST HALF OF THE STAPLE LINE WAS FORMED, BUT THE NEXT QUARTER OF THE STAPLE LINE WAS NOT, THEN THE LAST QUARTER FIRED BUT NO STAPLES FORMED. THEY OVER-SEWED THE STAPLE LINE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WERE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282263 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CH3J

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G