BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3941282 · Received July 17, 2014

    Report

    Report Number
    9680837-2014-00058
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 24, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT HOOK MCO205B 0.3MM 90DEG ANTERIOR, 510K: EXEMPT, LOT# 140203, MFR DATE FEB. 2014 (B)(4). THE PRODUCT ANALYSIS DETERMINED THAT FOR BOTH THE ANTERIOR AND POSTERIOR HOOKS (HOOK MCO205A 0.3MM 90DEG POSTERIOR AND HOOK MCO205B 0.3MM 90DEG ANTERIOR), ¿THE TIP OF THE HOOK IS BROKEN. THE MISSING FRAGMENT WAS NOT RETURNED. CONSIDERING ITS SIZE (APPROXIMATIVELY 0.1MM), THE PATIENT RISK IS VERY LOW. MOREOVER, IT APPEARS THAT THE EVENT HAPPENED DURING THE REPROCESSING OF THE INSTRUMENT. THE DISTAL PART OF THE INSTRUMENT IS BENT. NO MANUFACTURING OR MATERIAL DEFECT WAS FOUND. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS AN EXCESSIVE EFFORT DURING THE USE OR THE REPROCESSING OF THE INSTRUMENT.¿ (B)(4).

    Description of Event or Problem · 1

    THE DEVICE CAME IN FOR SERVICE WITH THE COMMENT ¿ALREADY BROKEN.¿ THE PRODUCT ANALYSIS INDICATED THAT THE TIP OF THE HOOK WAS BROKEN AND THE MISSING FRAGMENT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418445 MICROFRANCE® INSTRUMENT HOOK, MICROSURGICAL EAR JYL XOMED MICROFRANCE MFG MCO205A 140203

    Patients

    Seq Age Sex Outcome Treatment
    1