BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3071477 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01916
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 29, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT 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 ADJUSTING KNOB WORKED AS INTENDED AND WITHOUT ANY DIFFICULTIES. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. : INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DAY AFTER A LAP LOW ANTERIOR RESECTION, A BLEEDING WAS CONFIRMED ON COLON FIBERSCOPE. A BLEEDING WAS STOPPED WITH THE CLIP VIA THE TRANSANAL ROUTE. BLEEDING AMOUNT WAS SMALL. NO BLOOD TRANSFUSION WAS PERFORMED. THE PATIENT TENDED TO BLEED BECAUSE OF HEPARIN ADMINISTRATION. DURING INITIAL PROCEDURE, THE PURSE STRING DEVICE WAS USED FOR ANVIL'S PURSE STRING SUTURE. ULTRA STAPLERS(MANUFACTURED BY COMPETITOR) WAS USED FOR ANALIS STAPLING. THE THICKNESS OF THE TISSUE WAS USUAL. THERE WAS NO UNEXPECTED RESISTANCE AT FIRING. ALL STAPLES WERE FORMED B-FORM SHAPE. NEITHER LEAK NOR BLEEDING WAS CONFIRMED DURING THE OPERATION. THE DEVICE AND THE ANVIL MIGHT BE CLOSED LOOSELY BEFORE FIRING. WHEN COLON FIBERSCOPY WAS PERFORMED AFTER THE OPERATION, ALL STAPLES WERE FORMED COMPLETELY. AS OF NOW, THE PATIENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171621 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AZ4F

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention