BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4034644 · Received August 25, 2014

    Report

    Report Number
    9680837-2014-00071
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 31, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. SUSPECT MEDICAL DEVICE * (B)(4) INSTRUMENT XOMED (B)(4) INSTRUMENT XOMED (B)(4), (B)(4), FR 3160, MODEL: MCO205A LOT: 131002, MANUFACTURED DATE: OCTOBER 2013; SUSPECT MEDICAL DEVICE (B)(4) INSTRUMENT XOMED; (B)(4), FR 3160 MODEL: MCO205B LOT: 131001 MANUFACTURED DATE: OCTOBER 2013; SUSPECT MEDICAL DEVICE * (B)(4) INSTRUMENT XOMED (B)(4), FR 3160 MODEL: MCO205B LOT: 131002 MANUFACTURED DATE: OCTOBER 2013. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4). PRODUCT EVALUATION: ANALYSIS FOUND THAT ON BOTH OF MCO205A (2 RETURNED), LOTS 131101 AND 131002, THE TIP OF THE HOOK IS BROKEN. THE MISSING FRAGMENT WAS NOT RETURNED. CONSIDERING ITS SIZE (APPROXIMATELY 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 THESE BREAKAGES IS AN EXCESSIVE EFFORT DURING THE USE OR THE REPROCESSING OF THE INSTRUMENTS. ANALYSIS FOUND THAT ON BOTH OF (B)(4) (2 RETURNED), LOTS 131001 AND 131002, THE TIP OF THE HOOK IS BROKEN. THE MISSING FRAGMENT WAS NOT RETURNED. CONSIDERING ITS SIZE (APPROXIMATELY 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 THESE BREAKAGES IS AN EXCESSIVE EFFORT DURING THE USE OR THE REPROCESSING OF THE INSTRUMENTS. RESULTS: FRACTURE PROBLEM; STRESS PROBLEM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICES WERE ¿ONLY USED ONCE.¿ ANALYSIS FOUND THAT THE TIPS HAD BROKEN AND DETACHED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511020 MICROFRANCE® INSTRUMENT HOOK, MICROSURGICAL EAR JYL XOMED MICROFRANCE MFG MCO205A 131101

    Patients

    Seq Age Sex Outcome Treatment
    1