BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3111401 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02311
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP: THE ORIGINAL PROCEDURE WAS PERFORMED AT 8AM MONDAY, THE REOPERATION OCCURED AT 5:45AM TUESDAY. NO DETAILS ARE KNOWN REGARDING PRE/POST OP MEDS OR BLOOD PRESSURE. WHERE ON THE STAPLE LINE DID THIS OCCUR? WORST BLEEDING WAS AROUND 3RD FIRING FROM THE BOTTOM. HOW IS THE PATIENT CURRENTLY? GOOD. WAS RELEASED THE DAY AFTER THE RE-OPERATION WITH NO COMPLICATIONS I AM AWARE OF. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? YES. ANY UNUSUAL ANTICOAGULANTS USED? LOVENOX PRE-OP. BLEEDING RISKS? NO. DID THE PATIENT RECEIVE A TRANSFUSION? YES. BASED ON THE VIDEO EVIDENCE PROVIDED IT CANNOT BE DETERMINED THE CAUSE OF THE COMPLICATION. THE ONLY POSSIBLE SCENARIOS WOULD INCLUDE INTERACTIONS BETWEEN THE TISSUE, BUTTRESSING COMBINATION AND CARTRIDGE SELECTION REACTING TO BEING COMPRESSED INTO COMPLIANCE DURING FIRING MAY HAVE RESULTED IN SOME MINOR STAPLE CARTRIDGE DECK DEFLECTION AND STAPLE LINES WITH SOME HIGH "B" FORMED STAPLES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST LAPAROSCOPIC SLEEVE GASTRECTOMY THE PATIENT HAD TO BE RE-OPERATED DUE TO A BLEEDING STAPLE LINE. SEAMGUARD WAS USED ON ALL FIRINGS. FIRST FIRING WAS BLACK CARTRIDGE WITH BUTTRESS AND ALL THE REST WERE GREEN WITH BUTTRESS. THE STAPLER PERFORMED AS EXPECTED, PROPER B FORMED STAPLES APPEARED TO BE PRESENT. THE SLEEVE WAS LEAK TESTED PRIOR TO CLOSING AND THE TEST INDICATED NO ISSUES. DEVICES WERE DISCARDED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212612 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention