BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS

    MDR report key: 1970607 · Received June 26, 2010

    Report

    Report Number
    1970607
    Event Type
    Injury
    Date Received
    June 26, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DOING A COLOSTOMY TAKEDOWN USING 29MM PROXIMATE ILS LOT # G4RL75. SURGEON WAS UP IN THE ABDOMEN SETTING THE ILS TIP/INSTRUMENTS WHILE PHYSICIAN'S ASSISTANT WAS DOING THE INSTRUMENTATION DOWN THE RECTUM. THE INSTRUMENT WAS ENGAGED AND DEPLOYED CORRECTLY PER THE PHYSICIAN'S ASSISTANT AND WAS SUCCESSFULLY REMOVED FROM THE RECTUM. AFTER REMOVAL OF THE INSTRUMENT THE SURGEON NOTICED THAT THE ANASTOMOSIS WAS NOT COMPLETE. A SECOND SURGEON WAS CONSULTED. A DIVERTING ILEOSTOMY HAD TO BE PERFORMED TO ALLOW INJURY TO THE RECTUM TO HEAL BEFORE ATTEMPTING ANOTHER SURGICAL ANASTOMOSIS (ANOTHER 6 WEEKS).HEALTH PROFESSIONAL'S IMPRESSION: A DOUGHNUT MAY HAVE BEEN MISSING FROM THE DEVICE. HOWEVER, AWAITING MANUFACTURER'S REVIEW AND OPINION.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, PROXIMATE ILS: WHEN DEVICE IS AVAILABLE AFTER PATHOLOGY REVIEW, REP WILL COME OUT TO EXAMINE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, LLC * G4RL75

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R