BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3081249 · Received April 26, 2013

    Report

    Report Number
    3005075853-2013-02007
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION: HOW WAS IT CONFIRMED THAT THE ANVIL WAS SECURED TO THE TROCAR? THEY HEARD DE "CLICK" AND SAW THE ORANGE LINE COMPLETELY BEFORE TO ATTACHMENT. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? WHERE WITHIN THE GREEN TISSUE COMPRESSION/GAP SETTING SCALE WAS THE ORANGE INDICATOR SET FOR FIRING? AT THE MIDDLE TO GAP SETTING. WHAT WAS THE APPEARANCE OF THE BREAKAWAY WASHER? COMPLETELY. WERE STAPLES OBSERVED IN THE TISSUE? NO. WHAT WAS THE APPEARANCE OF THE DONUTS? NO COMPLETELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY PROCEDURE, THE INTRALUMINAL STAPLER DID NOT CUT; THE DONUTS DID NOT FORM PROPERLY. THE FIRING WAS ON THE ESOPHAGUS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. TWO DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182557 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CH3M

    Patients

    Seq Age Sex Outcome Treatment
    1