BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1860715 · Received October 7, 2010

    Report

    Report Number
    3005075853-2010-05762
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 15, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REQUESTED ADDITIONAL INFORMATION AND RECEIVED THE FOLLOWING RESPONSE: WHAT WAS THE PATIENT'S PRE-OP DIAGNOSIS? LOW RECTAL CANCER. WHAT WAS THE QUALITY OF THE TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? UNKNOWN. DID THE EXTENDED OR TIME HAVE A NEGATIVE IMPACT ON THE PATIENT? IF SO, PLEASE EXPLAIN. THE PATIENT NEEDED THE MORE ANESTHETIC. 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. 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 RECTAL "ANUS-SAVING" PROCEDURE, AFTER THE SURGEON FIRED THE DEVICE, THE STAPLES WERE MALFORMED. SO THE SURGEON USED HAND SEWING TO ANASTOMOSE. THE PATIENT'S ANUS WAS SAVED, BUT SHE LOST BLOOD 250ML, AND WAS TRANSFUSED WITH 400ML OF BLOOD. AS A RESULT OF THE DIFFICULTIES ENCOUNTERED WITH THIS DEVICE, THE PROCEDURE WAS PROLONGED 90 MINUTES. NOW THE PATIENT IS FINE.

    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 46 YR Other| R