BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1822670 · Received November 27, 2007

    Report

    Report Number
    1527736-2007-06563
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Report Date
    September 17, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. THE MFG RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMOID PROCEDURE, THE ANASTOMOSIS WAS INCOMPLETE. THE CASE WAS COMPLETED WITH SUTURES. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL GDW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HE6F

    Patients

    Seq Age Sex Outcome Treatment
    1