BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC ACE 36 CM

    MDR report key: 639184 · Received July 25, 2005

    Report

    Report Number
    1527736-2005-03252
    Event Type
    Malfunction
    Date Received
    July 25, 2005
    Date of Event
    June 29, 2005
    Report Date
    June 29, 2005
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, THE WHITE TISSUE PAT MELTED MIDWAY BETWEEN THE WHITE PAD AND THE BLADE PAD. NO PORTION OF THE PAT HAD FALLEN INTO PT. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC ACE 36 CM ULTRACISION HARMONIC ACE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA Y45026

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN