BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH)

    MDR report key: 2853368 · Received November 30, 2012

    Report

    Report Number
    3005075853-2012-05419
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL BENT, THE KNIFE DAMAGED; THE BREAKAWAY WASHER WAS PRESENT AND WITH AN OFF-CENTER CUT. IT APPEARS POSSIBLE THAT THE ANVIL WAS PUSHED FAR ENOUGH OFF CENTER TO RESULT IN AN OFF CENTER CUT OF THE BREAKAWAY WASHER AND DAMAGE THE KNIFE BY PRESSING IT HARD ENOUGH AGAINST THE ANVIL. THIS SITUATION NORMALLY OCCURS WHEN THE TISSUE IS NOT EVENLY DISTRIBUTED IN THE DEVICE. HOWEVER, IT COULD NOT BE DETERMINED WHAT MAY HAVE CAUSED THE ANVIL TO BECOME OFF CENTER. IT SHOULD BE NOTED THAT ENSURING THAT THE TISSUE THICKNESS IS WITHIN THE INDICATED RANGE, AND THAT IT IS EVENLY DISTRIBUTED IN THE DEVICE. EXCESS TISSUE ON ONE SIDE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION AND CAN RESULT IN STAPLE LINE LEAKAGE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY, IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT; HOWEVER THE WASHER NOT CUT CIRCUMFERENTIALLY DUE TO THE DAMAGED KNIFE. THE STAPLE LINE WAS COMPLETE AND SOME STAPLES WERE NOT PROPERLY FORM DUE TO A MISALIGNMENT CAUSED BY THE BENT ANVIL. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STARR PROCEDURE, THE DEVICE DID NOT STAPLE BUT CUT. THERE WAS ¾ CUT AND UNFORMED STAPLES. SOME OF THE STAPLES STUCK OUT OF THE STAPLER. THE ACOUSTIC FEEDBACK HEARD DURING FIRING. THERE WAS NOT TOO MUCH TISSUE. THE CASE WAS COMPLETED BY SUTURING BY HAND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CF0M

    Patients

    Seq Age Sex Outcome Treatment
    1