BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2041727 · Received April 6, 2011

    Report

    Report Number
    3005075853-2011-01361
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 18, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED. THE TARGET TISSUE WAS THICK. AT THE 1ST FIRING, THE WASHER WAS UNCUT, SO THE SAME ANVIL WAS USED WITH THE 2ND INSTRUMENT. ALL STAPLES WERE UNFORMED AT THE 1ST FIRING.

    Additional Manufacturer Narrative · 1

    (B)(4). SAFETY RELEASE DAMAGED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE SAFETY DAMAGED. IT APPEARS THAT AN ATTEMPT WAS MADE TO FIRE THE DEVICE WITH THE SAFETY ENGAGED. IT SHOULD BE NOTED THAT TO FIRE THE DEVICE, DRAW THE RED SAFETY BACK TOWARD THE ADJUSTING KNOB UNTIL IT SEATS INTO THE BODY OF THE DEVICE. IF THE SAFETY CANNOT BE RELEASED, THE DEVICE IS NOT IN THE SAFE FIRING RANGE. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE 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. 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 A LOW ANTERIOR RESECTION PROCEDURE, WHEN THE SAFETY WAS RELEASED, THE SAFETY BROKE. THE DOCTOR FIRED THE DEVICE WITHOUT BEING AWARE OF IT. THE STAPLES WERE UNFORMED. FORTUNATELY, THERE WAS ENOUGH SPACE TO BE FIRED AGAIN ON THE BOWEL, SO ANOTHER INSTRUMENT WAS FIRED WITHOUT CHANGING THE FIRST ANVIL. THE FIRING WAS COMPLETED WITHOUT ANY PROBLEMS. THE BROKEN PIECE OF THE SAFETY AND THE USED ANVIL WERE DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1