BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3932078 · Received July 14, 2014

    Report

    Report Number
    9680837-2014-00056
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 19, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT EVALUATION: ANALYSIS FOUND THAT THE MOBILE JAW OF THE INSTRUMENT IS MISSING. THE FRAGMENT WAS NOT RETURNED BY THE CLIENT. CONSIDERING THE SIZE OF THE FRAGMENT (1CM) AND THE TYPE OF SURGERY (EAR MICROSURGERY), THE FRAGMENT IS PROBABLY NOT IN PATIENT CONTACT. THE FIXED JAW IS BADLY DAMAGED. THE PIN BETWEEN THE BODY AND THE MOBILE JAW IS BROKEN AND ITS FRAGMENT IS STILL ON THE FORCEPS. THE MOST PROBABLE CAUSE IS AN EXCESSIVE EFFORT DURING THE USE OR THE REPROCESSING OF THE INSTRUMENT. RESULTS: FRACTURE PROBLEM. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED WITH A REQUEST FOR REPAIR. ANALYSIS FOUND THAT THE MOBILE JAW OF THE INSTRUMENT IS MISSING. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409349 MICROFRANCE® INSTRUMENT FORCEPS, ENT KAE XOMED MICROFRANCE MFG MCO13C 140203

    Patients

    Seq Age Sex Outcome Treatment
    1