BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONIC

    MDR report key: 2100953 · Received May 20, 2011

    Report

    Report Number
    2100953
    Date Received
    May 20, 2011
    Date of Event
    January 12, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    LFL
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ROOM CIRCULATOR RETURNING FROM LUNCH WAS NOTIFIED BY RELIEVING CIRCULATOR THAT A PIECE OF THE HARMONIC SCALPEL HAD BROKEN OFF AND WAS STILL IN THE PATIENT'S BODY. OPERATOR OF THE EQUIPMENT APPLIED THE TIP OF THE SCALPEL AGAINST ANOTHER METAL INSTRUMENT CAUSING SIGNIFICANT VIBRATION OF THE SCALPEL. EQUIPMENT ALARMED SEVERAL TIMES. TIP BROKE OFF AFTER MULTIPLE CLEANING ATTEMPTS AND CONTINUED USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC INSTRUMENT, ULTRASONIC SURGICAL, CURVED SHEARS LFL ETHICON ENDO-SURGERY, INC. ULTRACISION 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR OTHER