BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON

    MDR report key: 3020006 · Received March 25, 2013

    Report

    Report Number
    3005075853-2013-01395
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE PAN DISLODGED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IN WHICH ECHELON STAPLER WAS THE CARTRIDGE USED? EC60A. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? STOMACH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 4TH. DURING WHICH STROKE DID THE EVENT OCCUR? BEFORE THE 1ST. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLACK, GREEN. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? YES, RELOAD WOULD NOT SLIDE INTO STAPLER CARTRIDGE HOUSING. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? IRRELEVANT QUESTION, STAPLER COULD NOT BE FIRED AS RELOAD WOULD NOT LOAD. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? N/K. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? N/K. THE ANALYSIS RESULTS FOUND THAT ONE RELOAD WAS RECEIVED NON STERILE, UNFIRED, AND WITH THE PAN PARTIALLY ENGAGED AT PROXIMAL END. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, 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 UNKNOWN PROCEDURE, THE DEVICE WAS A DUD. WE TRIED IT AND A PIECE BROKE OFF. USED A NEW STAPLE FROM A NEW BOX AND NO PROBLEM. NO ADVERSE EVENT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122529 BLUE RELOAD FOR ECHELON STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1