BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 380788 · Received March 6, 2002

    Report

    Report Number
    1527736-2002-00385
    Event Type
    Injury
    Date Received
    March 6, 2002
    Date of Event
    February 11, 2002
    Report Date
    February 12, 2002
    Manufacturer
    ETHICON ENDO-SURGERY-ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM (BLADE, HANDPIECE, GENERATOR) WAS NOT ACHIEVING THE PROPER LEVEL OF HEMOSTASIS DURING A LAPAROSCOPIC PROSTECTOMY CASE. THE SYSTEM WAS EMITTING NORMAL SOUNDS. THE BLADE WAS REPLACED AND THE TISSUE EFFECT IMPROVED. THE SURGEON COMMENTED THE BLOOD LOSS WAS APPROX. 1600CC FOR THE CASE WHEN IT SHOULD HAVE BEEN THE SAME HAND PIECE AND GENERATOR, AND THE NEW BLADE. THE BLADE WAS DISCARDED. NO OTHER PT ISSUES WERE REPORTED.

    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 Other