BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE STAPLER RELOAD

    MDR report key: 3770518 · Received April 24, 2014

    Report

    Report Number
    3005075853-2014-02795
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE TCR10 RELOAD WAS RECEIVED IN GOOD VISUAL CONDITION AND FULLY FIRED. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE RELOAD. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN PANCREATICODUODENECTOMY, THE STAPLES WERE OVERLY BENT WHEN THE DEVICE WAS FIRED ON THE JEJUNUM AT THE 2ND FIRING. THE STAPLES WERE FORMED PROPERLY WHEN IT WAS USED ON THE GASTRIC BODY AT THE 1ST FIRING. THE DOCTOR WAITED 15 SECONDS PRIOR TO THE FIRING. THERE WAS NO UNEXPECTED RESISTANCE IN FIRING. ECHELON DEVICE LOADING A BLUE CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249611 PROXIMATE STAPLER RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CK69

    Patients

    Seq Age Sex Outcome Treatment
    1