BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1843874 · Received September 24, 2010

    Report

    Report Number
    3005075853-2010-05490
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 PARTIALLY CUT AND THERE WERE NO STAPLES PRESENT; HOWEVER THE KNIFE AND WASHER WERE NOTED TO BE INDENTED. THIS DAMAGE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER A HARD OBJECT SUCH AS A CLIP. HARD OBJECTS SHOULD BE AVOIDED AS THEY CAN CAUSE INTERFERENCE IN THE FIRING MECHANISM RESULTING IN AN INCOMPLETE FIRING STROKE, AND IN PARTIALLY FIRED STAPLES AND AN INCOMPLETE CUT. 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 WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE CUT LINE WAS COMPLETE AND JAGGED DUE TO THE DAMAGE OBSERVED TO THE KNIFE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION AND COLOSTOMY PROCEDURE, THE SURGEON FIRED ACROSS THE COLON ON THE INITIAL FIRING AND WHEN HE OBSERVED THE STAPLE LINE, IT HAD PARTIALLY FIRED THE STAPLE LINE. THE ANTERIOR SIDE OF THE STAPLE LINE DID NOT FORM AND HAD PROXIMATELY FORMED ONLY ON THE POSTERIOR HALF OF THE STAPLE LINE. HE NOTICED A LINE INDENTATION IN THE HOUSING WHEN HE OBSERVED THE DEVICE AFTER SURGERY AND FELT HE MAY HAVE FIRED OVER A CLIP. HE THEN PERFORMED A PERMANENT COLOSTOMY ON THE PATIENT DUE TO THERE WAS NO MARGIN TO DO ANOTHER ANASTOMOSIS THAT LOW IN THE COLON. PATIENT IS STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R