BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR QTY

    MDR report key: 4444705 · Received January 23, 2015

    Report

    Report Number
    1717344-2015-00051
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 21, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : 01/23/2015. DATE OF FOLLOW-UP REPORT : 02/10/2015. THE INCIDENT ULTRASONIC DISSECTOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DISPOSABLE HAND PIECE REVEALED THAT THE DEVICE HAD BEEN USED AND THE STATIC PART OF THE JAW HAD BROKEN OFF. THE BROKEN PIECE WAS RETURNED WITH THE REST OF DEVICE. THE REMAINING WAVEGUIDE AND THE BROKEN PIECE WERE INSPECTED UNDER MAGNIFICATION TO IDENTIFY THE POINT OF INITIAL CONTACT AND FRACTURE. IT WAS CONCLUDED THAT THE TITANIUM WAVEGUIDE FRACTURED DURING USE AND EVENTUALLY BROKE OFF. THE TITANIUM WAVEGUIDE MAY HAVE CAME IN CONTACT WITH A HARD METALLIC OBJECT SUCH AS HEMOSTAT OR RETRACTOR AS EVIDENCED BY THE BREAK POINT AND METALLIC SCRAPING. THE USER¿S GUIDE FOR THIS SYSTEM WARNS: CONTACT BETWEEN THE ACTIVE BLADE AND OTHER METAL OBJECTS (HEMOSTATS, CLIPS, STAPLES, RETRACTORS, ETC.) MAY RESULT IN UNINTENDED DAMAGE TO TISSUE AND/OR DEVICE FAILURE

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC RECTUM RESECTION, THE DEVICE WAS THOUGHT TO HAVE COME INTO INADVERTENT CONTACT WITH A METALLIC INSTRUMENT ALSO IN USE DURING THE PROCEDURE AND WAS NOT WORKING AS EXPECTED. THE DEVICE WAS REMOVED FROM THE PATIENT AND WHILE A NURSE WAS CLEANING THE JAWS, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54756 ULTRASONIC DISSECTOR QTY ULTRASONIC DISSECTOR QTY LFL COVIDIEN LP SCD396 42520076X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ULTRASONIC REUSABLE GENERATOR - SERIAL # UNKNOWN