BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 2961904 · Received February 14, 2013

    Report

    Report Number
    3005075853-2013-00626
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DELAMINATION PACKAGE WAS VISUALLY EXAMINED AND TYVEK DELAMINATION WAS CONFIRMED. TYVEK RIPPED, OR "SPLIT", AND STUCK TO THE BLISTER FLANGE WHEN PACKAGE WAS OPENED DUE TO TYVEK DELAMINATION (SEPARATION OF TYVEK LAYERS.) TYVEK DELAMINATION CAUSES THE PACKAGE TO BE DIFFICULT TO OPEN AND MAY CAUSE DEVICE TO BECOME CONTAMINATED. REMOVAL OF THE DEVICE WAS NOT HINDERED AS THE DELAMINATION WAS ONLY ALONG THE EDGE OF THE BLISTER FLANGE. THE PACKAGE BLISTER EXHIBITED NO DEFECTS AND THERE WAS EVIDENCE OF SEAL TRANSFER FROM THE TYVEK TO THE BLISTER FLANGE ON THE ENTIRE CIRCUMFERENCE OF THE BLISTER. PACKAGE STERILE INTEGRITY WAS NOT AFFECTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DELAMINATION PACKAGE WAS VISUALLY EXAMINED AND TYVEK DELAMINATION WAS CONFIRMED. TYVEK RIPPED, OR SPLIT, AND STUCK TO THE BLISTER FLANGE WHEN PACKAGE WAS OPENED DUE TO TYVEK DELAMINATION (SEPARATION OF TYVEK LAYERS.) TYVEK DELAMINATION CAUSES THE PACKAGE TO BE DIFFICULT TO OPEN AND MAY CAUSE DEVICE TO BECOME CONTAMINATED. REMOVAL OF THE DEVICE WAS NOT HINDERED AS THE DELAMINATION WAS ONLY ALONG THE EDGE OF THE BLISTER FLANGE. THE PACKAGE BLISTER WAS FINE WITH NO DEFECTS AND THERE WAS EVIDENCE OF SEAL TRANSFER FROM THE TYVEK TO THE BLISTER FLANGE ON THE ENTIRE CIRCUMFERENCE OF THE BLISTER. PACKAGE STERILE INTEGRITY WAS NOT AFFECTED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE TECH BEGAN TO OPEN THE PACKAGE, IT WAS NOTICED THAT THE TYVEK WAS SPLIT AND THE STERILITY HAD BEEN COMPROMISED. ANOTHER LIKE DEVICE WAS USED AND PROCEEDED WITH THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT WITH USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64845 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AU2H

    Patients

    Seq Age Sex Outcome Treatment
    1