BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3050226 · Received April 10, 2013

    Report

    Report Number
    3005075853-2013-01689
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 18, 2013
    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
    IT
    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. 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. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THREE PICTURES OF THE DEVICE WERE RECEIVED. BASED ON THE EVENT DESCRIPTION AND PHOTOGRAPHIC EVIDENCE; THE POTENTIAL CAUSE OF THIS EVENT WAS HAS BEEN IDENTIFIED AS EXTREME TISSUE IMBALANCE CIRCUMFERENTIALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STARR PROCEDURE, THE LEVER DID NOT ACTIVATE AND COULD NOT REACH THE LIMIT. THE STAPLER WAS REOPENED AND THEN CLOSED AGAIN BUT THE SUTURE PERFORMED WAS INCOMPLETE (BETWEEN 11 HOUR AND 2 HOUR). THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149836 PROXIMATE** HCS PROCEDURE FOR PROLAPSE AND HEMORRHOIDS (PPH) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU6A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR