BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESU FORCE 2-2PCH

    MDR report key: 2122943 · Received June 10, 2011

    Report

    Report Number
    1717344-2011-00458
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING A BIOPSY ON A SESSILE POLYP DURING A COLONOSCOPY USING NON-COVIDIEN FORCEPS AND REUSABLE CABLE, A BANG SOUND WAS HARD COMING FROM INSIDE THE PATIENT. AFTER THE SOUND WAS HEARD, IT WAS NOTICED THAT THE PATIENT HAD THREE PERFORATIONS IN THE COLON. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN EMERGENCY RIGHT HEMICOLECTOMY. THE PATIENT THEN WENT INTO SEPTIC SHOCK AND WAS TRANSFERRED TO A THIRD FACILITY FOR ADDITIONAL CARE. THE PATIENT IS REPORTED AS BEING IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESU FORCE 2-2PCH ELECTROSURGICAL GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| O| R BOSTON SCIENTIFIC HOT BIOPSY FORCEPS, LOT# UNK| REUSABLE OLYMPUS CABLE, (B)(4)