BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2994353 · Received March 8, 2013

    Report

    Report Number
    3005075853-2013-01128
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY THE CONTACT. 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. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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 CUT WAS NOT A PERFECT CIRCLE DUE TO THE DAMAGED KNIFE. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEMORRHOIDECTOMY PROCEDURE A PPH DEVICE WAS USED. AFTER FIRING THE DEVICE, IT DID NOT OPEN. SURGEON TRIED TO OPEN THE STAPLER BUT THIS WAS NOT POSSIBLE AND CUT THE STAPLER WITH "DIATHERMIE" OUT OF THE RECTUM. PATIENT LOST 200 ML BLOOD. PATIENT HAD TO STAY SEVERAL DAYS IN THE HOSPITAL. PRODUCT SPECIALIST NOTICED WASHER HAS BEEN CUT AT TWO PLACES AND KNIFE WAS DAMAGED AT SEVERAL PLACES. PROCEDURE COMPLETED BY HAND SUTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100222 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU2J

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization