BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 3122837 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02480
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. RESULTS: NONCONFORMING CARTRIDGE WELD THE ANALYSIS RESULTS SHOWED THAT ONE INSTRUMENT WAS RETURNED WITH THE NOSE OPEN AND NON-FUNCTIONAL DUE TO INSUFFICIENT NOSE WELD. IN ADDITION, ONE STAPLE WAS FOUND IN THE CARTRIDGE NOSE. NO FUNCTIONAL TEST WAS PERFORMED DUE TO THE CONDITION OF THE DEVICE. 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 MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN PROCEDURE, THE FIRING FORCE WAS HIGHER THAN EXPECTED AND THE TRIGGER COULD NOT BE GRASPED AND STAPLES COULD NOT BE DEPLOYED AT THE 3RD FIRING WHEN THE DEVICE WAS USED FOR CLOSING THE ABDOMEN. THE DEVICE WAS FIRED OUTSIDE OF THE PATIENT, AND THE STAPLES WERE MALFORMED. ANOTHER DEVICE 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
    224507 PROXIMATE** SKIN STAPLER 35 WIDE REMOVABLE (SKIN) GDT ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1