BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STRP THI

    MDR report key: 3152827 · Received June 8, 2013

    Report

    Report Number
    3005075853-2013-02876
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 16, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT ONE DEVICE ARRIVED IN GOOD VISUAL CONDITIONS AND VOID OF STAPLES. THE DEVICE WAS MANUALLY LOADED WITH STAPLES AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS FIRED AND IT FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE; THE STAPLE LINE WAS NOTED TO BE COMPLETE. IT IS IMPORTANT TO ENSURE THAT THE RETAINING PIN IS SEATED IN THE ANVIL BEFORE FIRING. IF THE PIN IS NOT PROPERLY POSITIONED, STAPLES MAY NOT FORM PROPERLY, WHICH MAY RESULT IN LEAKAGE OR DISRUPTION OF THE STAPLE LINE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SIGMOID PROCEDURE THE CLIPS DID NOT CLOSE. NO STAPLE LINE HAS BEEN SET, NO NOISE, NO HIGHER EFFORT. A NEW DEVICE WAS OPENED TO FINISH THE SURGERY. THERE WERE NO CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255665 PROX ACCESS 55MM ART STRP THI STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AU43

    Patients

    Seq Age Sex Outcome Treatment
    1