BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE EZ-C

    MDR report key: 642569 · Received October 20, 2005

    Report

    Report Number
    1717344-2005-00140
    Event Type
    Injury
    Date Received
    October 20, 2005
    Date of Event
    September 12, 2005
    Report Date
    September 12, 2005
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2005 IT WAS REPORTED TO THE COMPANY THAT DURING A PROCEDURE TO COLLECT A POLYP IN WHICH THE SURGEON WAS ALSO USING A BOSTON SCIENIFIC SNARE, THE STAFF REPORTED HEARING A "POP" AND A PERFORATION WAS THEN OBSERVED AT THE HEPATIC FLEXURE OF THE BOWEL. THE PT WAS REPORTEDLY RETURNED TO SURGERY ON THE SAME DAY TO REPAIR THE PERFORATION. THE CALLER INDICATED THE POP MAY HAVE BEEN A RESULT OF THE IGNITION OF METHANE GAS IN THE PT'S BOWEL AND INQUIRED ABOUT THE RISKS ASSOCIATED WITH THE GENERATOR AND METHANE GAS. THE CALLER WAS ALSO ADVISED THAT THEY MAY WANT TO CHECK WITH THE MAKERS OF THE SNARE AS WELL. IN 2005 THE FACILITY'S RISK MANAGER REPORTED TO THE COMPANY THAT THE PT RECEIVED A COLOSTOMY DUE TO THE ALLEGED "DEVICE FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE EZ-C ELECTROSURGICAL GENERATOR GEI VALLEYLAB * NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R