BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STAP THIC

    MDR report key: 1083032 · Received July 23, 2008

    Report

    Report Number
    3005075853-2008-00633
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 26, 2008
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/23/2008. EVALUATION SUMMARY: 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 POSSIBLE THAT THE RETAINING PIN WAS NOT SEATED IN THE ANVIL. BEFORE FIRING THE RETAINER PIN SHOULD BE CHECKED TO ENSURE PROPER INSERTION. IF THE PIN IS NOT PROPERLY POSITIONED, STAPLES MAY NOT FORM PROPERLY, WHICH MAY RESULT IN LEAKAGE OR DISRUPTION OF THE STAPLE LINE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER FIRING, SOME OF THE STAPLES WERE MALFORMED. HE THEN USED HAND SEWING TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX ACCESS 55MM ART STAP THIC GDW ETHICON ENDO-SURGERY, LLC NA D4JV83

    Patients

    Seq Age Sex Outcome Treatment
    1