BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE ULTRASONIC DISSECTOR

    MDR report key: 3983234 · Received June 27, 2014

    Report

    Report Number
    1717344-2014-00560
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 WAVE GUIDE 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 PROBABLY 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 SYS 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.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DURING AN LADG PROCEDURE, A RED INDICATOR LIGHT WAS PROVIDED BY THE SYS AND THE DEVICE STOPPED WORKING. A NEW DISSECTOR WAS INSTALLED AND WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION WITH A PIECE OF THE ACTIVE WAVE GUIDE DISENGAGED. THE PIECE WAS RETURNED WITH THE REMAINDER OF THE WAVEGUIDE. THE DEVICE MAY HAVE BROKEN AFTER THE PROCEDURE DURING CLEANING OR DURING TRANSPORT TO COVIDIEN BOULDER. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377632 SINGLE ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ULTRASONIC REUSABLE BATTERY PACK - SERIAL # UNK| ULTRASONIC REUSABLE GENERATOR-SERIAL #UNK