BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1595582 · Received February 8, 2010

    Report

    Report Number
    3005075853-2010-00456
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 11, 2010
    Report Date
    January 12, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 1/20/2010: BEFORE THE CIRCULAR STAPLER WAS FIRED, THE ORANGE INDICATOR WAS WITHIN THE GREEN RANGE OF GAB SETTING SCALE. YES, THE STAPLER WAS COMPLETE FIRED (PLASTIC TO PLASTIC). YES, THE STAPLER CUT COMPLETELY. SURGEON IS NOT 100% SURE ABOUT THE STAPLES, BUT HE THINKS THEY WERE B-SHAPED. (B)(6). ADDITIONAL INFORMATION RECEIVED ON 1/27/2010: THE ONLY IMPACT TO THE PATIENT WAS THE DURATION OF THE PROCEDURE, WHICH WAS PROLONGED FOR 30-45 MINUTES DUE TO MANUAL SUTURING. THE PATIENT HEALTH WAS NOT IMPACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE CIRCULAR STAPLER WAS FIRED, BUT AFTER THAT, SURGEON COULDN`T OPEN THE INSTRUMENT. HEAD OF THE STAPLER WAS JAMMED AND WHEN THEY TRIED TO REMOVE THE INSTRUMENT, THEY TORE ANASTOMOSIS AND REMOVED THE STAPLER. AFTER THAT THEY MANUALLY PERFORMED ANASTOMOSIS. PROCEDURE PROLONGED 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA F4P08J

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR