BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISSECTOR INSERT CEV601-1 350MM DELAITRE [MXI/XOM]

    MDR report key: 2921062 · Received January 17, 2013

    Report

    Report Number
    9680837-2013-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 27, 2012
    Manufacturer
    MEDTRONIC MICROFRANCE
    Product Code
    LRC
    PMA / PMN Number
    K080257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION BY A QUALITY ENGINEER. THE PRODUCT ANALYSIS CONFIRMED THE REPORTED COMPLAINT [BREAK WITH FRAGMENT] AND FOUND THE SIDE OF THE PIN HOLE IS ABNORMALLY THIN. THE LACK OF THICKNESS IN THIS AREA HAS WEAKENED THE INSTRUMENT AND COULD HAVE LED TO THE BREAKAGE OBSERVED DURING THE USE OR FOLLOWING A SHOCK DURING THE USE OR THE REPROCESSING STEP. THE DEVICE WAS NOT RETURNED TO THE CUSTOMER; THE PRODUCT WAS UNDER WARRANTY AND WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 'INSERT STRING IS BROKEN AT THE PIN-HOLE LEVEL. THE BROKEN FRAGMENT IS MISSING AND THE PIN IS STILL FIXED ON THE JAWS. NO MATERIAL DEFECT HAS BEEN HIGHLIGHTED BUT IT HAS BEEN NOTED THAT THE PIN-HOLE SIDE ON THE STRING WAS ABNORMALLY THIN.' THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26185 DISSECTOR INSERT CEV601-1 350MM DELAITRE [MXI/XOM] INSTRUMENT, ENT MANUAL SURGICAL LRC MEDTRONIC MICROFRANCE CEV601-1 111201

    Patients

    Seq Age Sex Outcome Treatment
    1