BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2143001 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02664
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR. THE ANALYSIS RESULTS SHOWED THAT ONE ANVIL WAS RECEIVED WITH AN ANCILLARY TROCAR INSERTED. THE ANCILLARY TROCAR WAS REMOVED AND IT WAS NOTED THAT IT WAS MISALIGNED. IT WAS NOTED THAT THE ANCILLARY TROCAR WAS MOLDED INCORRECTLY RESULTING IN A DIMENSIONAL CHANGE CONSEQUENTLY INCREASING THE RESISTANCE FOR THE ATTACHMENT AND DETACHMENT OF THE ANCILLARY TROCAR. 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. NO BATCH RECORD REVIEW COULD BE PERFORMED AS NO BATCH NOR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION WERE COMPLETED ON (B)(4) 2011 AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THE BLUE PIN COULD ONLY STICK TOGETHER WITH EXTREME EFFORT. THE ADDITIONAL TROCAR IS "ABDOMINAL PROCESSED". NO FURTHER INFORMATION AVAILABLE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOW UP IS BEING CONDUCTED DESPITE STATEMENT OF NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE A 3500 A SUPPLEMENTAL WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1