BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSTAT ELECTROSURGICAL UNIT

    MDR report key: 2940780 · Received November 22, 2006

    Report

    Report Number
    1221941-2006-00042
    Event Type
    Injury
    Date Received
    November 22, 2006
    Report Date
    October 23, 2006
    Manufacturer
    MEDICAL SCIENTIFIC, INC.
    Product Code
    KNS
    PMA / PMN Number
    K913881
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION AVAILABLE FROM USER FACILITY. (B)(4).

    Description of Event or Problem · 1

    NOTE: EVENT DATE IS UNKNOWN. THE CUSTOMER REPORTED TO BOSTON SCIENTIFIC (BSC) ON (B)(6) 2006, THAT A PATIENT EXPERIENCED "SHOCKING INSIDE THE BODY" WHILE USING ENDOSTAT 11 REFURBISHED GENERATOR. NO PATIENT INJURY OR ILL EFFECTS WERE REPORTED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTAT ELECTROSURGICAL UNIT KNS MEDICAL SCIENTIFIC, INC. M0054080R0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention