BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASONIC DISSECTOR

    MDR report key: 3881763 · Received May 27, 2014

    Report

    Report Number
    1717344-2014-00451
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Report Date
    March 10, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 THE 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 PROBABLY CAME IN CONTACT WITH A HARD METALLIC OBJECT SUCH AS HEMOSTAT OR RETRACTOR AS EVIDENCED BY THE BREAK POINT AND METALLIC SCRAPING.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE WAS DEFECTIVE AND NO ADDITIONAL DETAILS WERE PROVIDED BY THE SITE CONTACT. THE DEVICE WAS RETURNED WITH A PIECE DISENGAGED FROM THE ACTIVE WAVEGUIDE. THE BROKEN PIECE WAS RETURNED WITH THE REMAINDER OF THE DISSECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311499 ULTRASONIC DISSECTOR ULTRASONIC DISSECTOR LFL COVIDIEN LP 255748X

    Patients

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