BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 4220277 · Received November 3, 2014

    Report

    Report Number
    1717344-2014-00959
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 3, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : 11/03/2014. DATE OF FOLLOW-UP REPORT : 12/01/2014. 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

    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 TOTAL LAPAROSCOPIC HYSTERECTOMY, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED AND FELL INTO THE PATIENT CAVITY. THE PIECE WAS RETRIEVED AND THERE WAS NO REPORTED PATIENT INJURY. A NEW DISSECTOR WAS INSTALLED ONTO THE SYSTEM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703522 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP SCD396 42100245X

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR ULTRASONIC REUSABLE GENERATOR: SERIAL # UNKNOWN