BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2897019 · Received January 4, 2013

    Report

    Report Number
    3005075853-2013-00055
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Report Date
    December 13, 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). BREAKAWAY WASHER CUT OFF CENTER THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH 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. IN ADDITION THE GUIDE FACE WAS PARTIALLY DETACHED. 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. NO FUNCTIONAL TEST WAS PERFORMING DUE TO THE CONDITION OF THE DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STARR PROCEDURE THE DEVICE DID NOT STAPLE BUT CUT, SUTURED BY HAND. STAPLES STUCK OUT OF INSTRUMENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4861 PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4U89T

    Patients

    Seq Age Sex Outcome Treatment
    1