BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 382101 · Received March 14, 2002

    Report

    Report Number
    1527736-2002-00462
    Event Type
    Injury
    Date Received
    March 14, 2002
    Date of Event
    August 23, 2001
    Report Date
    August 28, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE INSTRUMENT BROKE. A FOUR HOUR SURGERY DELAY RESULTED. NO INFO AVAILABLE ON HOW THE CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization GENERATOR, FOOTSWITCH AND HANDPIECE.