BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT TISSUE MORCELLATOR

    MDR report key: 516033 · Received March 17, 2004

    Report

    Report Number
    2914019-2004-00017
    Event Type
    Injury
    Date Received
    March 17, 2004
    Report Date
    March 12, 2004
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN EVENT HAD OCCURRED DURING THE USE OF THE LUMENIS VERSACUT TISSUE MORCELLATOR AFTER A PROSTATE ENUCLEATION PROCEDURE. ENUCLEATING THE PROSTATE WAS WELL DONE IN ABOUT 50 MIN, HOWEVER, WHEN THE DOCTOR USED THE VERSACUT, IT COULD NOT CUT THE TISSUE WELL. THE DOCTOR HAD BEEN TRYING TO CUT AND ABSORB THE TISSUE INTO THE BLADDER DURING 2 HOURS. AT THAT TIME, THERE WAS SOME DAMAGE BETWEEN THE BLADDER AND THE URETHRA. A SALINE SOLUTION WENT INTO THE ABDOMINAL INSIDE FROM THE DAMAGED PART. AS A RESULT, A LAPAROTOMY OPERATION WAS PERFORMED ON THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSACUT TISSUE MORCELLATOR SURGICAL DELIVERY DEVICES GEX LUMENIS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention