BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2864537 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05538
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 16, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. CARTRIDGE PAN DISLODGED. THE ANALYSIS RESULTS THAT ONE DEVICE WAS RETURNED WITH NO VISUAL NON-CONFORMANCES AND WITH A CARTRIDGE RELOAD WITHOUT PAN PRESENT. IN ADDITION A CARTRIDGE PAN WAS FOUND LODGE INSIDE THE CHANNEL. THE PAN WAS REMOVED FROM THE CHANNEL AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD. THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE PAN BECAME DISLODGE FROM THE RELOAD, 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 GASTRIC BYPASS PROCEDURE, AFTER THE FIRST FIRING THEY ATTEMPTED TO RELOAD THE DEVICE FOR A SECOND FIRING ON THE JEJUNUM. HOWEVER, THEY WERE UNABLE TO LOAD THE SECOND CARTRIDGE INTO THE JAWS. UPON INSPECTION, IT APPEARS THE METAL PAN WAS STUCK IN THE JAWS. THE DEVICE WAS REMOVED AND A NEW ONE WAS PULLED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CF9H

    Patients

    Seq Age Sex Outcome Treatment
    1