BEUDAMED
    FDA Adverse Event Summary report: N

    ETHICON ENDO-SURGERY INC.

    MDR report key: 2941019 · Received August 30, 2006

    Report

    Report Number
    2941019
    Date Received
    August 30, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 29, 2006
    Manufacturer
    ETHICON ENDO-SURGERY INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ULTRACISION HARMONIC SCALPEL BROKE INSIDE PATIENT DURING LAPAROSCOPIC PROCEDURE. THE PORTION OF THE INSTRUMENT THAT BROKE OFF WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY INC. ULTRA CISION HARMONIC SCAPEL LFL ETHICON ENDO-SURGERY INC. LCSC 5 C4ET43

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR