BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® OTOLOGY INSTRUMENTATION

    MDR report key: 3875236 · Received June 16, 2014

    Report

    Report Number
    9680837-2014-00049
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    April 8, 2014
    Report Date
    June 4, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    LRC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT ANALYSIS DETERMINED THAT THE BASE OF THE FIXED JAW IS DAMAGED AND BENT. THE PIN OF THE MOBILE JAW IS BROKEN. A FRAGMENT IS STILL INSIDE THE JAW HOLE AND THE OTHER WAS NOT RETURNED WITH THE INSTRUMENT. THE PIN WAS PROBABLY BROKEN BECAUSE OF A FALL OR AN EXCESSIVE EFFORT ON THE FORCEPS, AS THE DEFORMATION OF THE FIXED JAW SHOWS. NO MATERIAL OR MANUFACTURING DEFECT HAS BEEN FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WOULD NOT GRASP. THIS WAS DISCOVERED PRE-OPERATIVELY. PRODUCT ANALYSIS DISCOVERED THAT A FRAGMENT OF THE INSTRUMENT WAS MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352678 MICROFRANCE® OTOLOGY INSTRUMENTATION INSTRUMENT, ENT MANUAL SURGICAL LRC XOMED MICROFRANCE MFG MCO13C 131101

    Patients

    Seq Age Sex Outcome Treatment
    1