BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 4111313 · Received September 23, 2014

    Report

    Report Number
    1717344-2014-00832
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 23, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HYSTERECTOMY, AFTER 45 MINUTES OF USE A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED AND FELL INTO THE PATIENT CAVITY. AN ALARM WAS PROVIDED BY THE SYSTEM PRIOR TO THE PIECE DISENGAGING AND THE SURGEON CONTINUED TO USE THE DEVICE. THE PIECE WAS SUCCESSFULLY RETRIEVED AND THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED USING A BIPOLAR INSTRUMENT (TYPE UNKNOWN) AND A MONOPOLAR HOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590283 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP SCD396 41770061X

    Patients

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