BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4029753 · Received August 22, 2014

    Report

    Report Number
    9680837-2014-00070
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Report Date
    July 30, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS INDICATES THAT THE TUBE OF THE INSTRUMENT IS BROKEN NEXT TO THE LASER WELD. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND. THE MOST PROBABLE CAUSE OF THE BREAK IS EXCESSIVE EFFORT DURING THE USE OR THE REPROCESSING OF THE INSTRUMENT. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER REQUESTED REPAIR OF THEIR SUCTION KNIFE. THE TUBE OF THE INSTRUMENT WAS BROKEN NEXT TO THE LASER WELD, WHICH RESULTED IN A DEVICE FRAGMENT. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508988 MICROFRANCE® INSTRUMENT KNIFE, EAR JYO XOMED MICROFRANCE MFG MCO5D 131101

    Patients

    Seq Age Sex Outcome Treatment
    1