BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4219422 · Received November 3, 2014

    Report

    Report Number
    9680837-2014-00094
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    October 7, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4). MATERIAL FRAGMENTATION. FOUR DEVICES WERE RETURNED FOR REPAIR/EVALUATION. THE PRODUCT ANALYSIS INDICATES THAT THE LOOPS WERE BROKEN RIGHT AFTER THE LASER WELDS. TWO OF THE FOUR FRAGMENTS WERE RETURNED. THE OTHER TWO WERE RECOVERED AND WERE NOT IN CONTACT WITH THE PATIENT. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND. THE CAUSE OF THE BREAKS COULD NOT BE DETERMINED. THE BREAKS MAY BE A RESULT OF EXCESSIVE EFFORT DURING USE. RESULT: STRESS PROBLEM. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR LOOP INSTRUMENTS BROKE AFTER THEIR FIRST USE. FOLLOW-UP INFORMATION INDICATES THAT EACH DEVICE WAS USED IN SEPARATE CASES. THE DATES OF EACH CASE ARE NOT KNOWN. THIS REGULATORY REPORT IS BEING SUBMITTED FOR LOT 130902. THE REMAINING LOOPS WILL BE SUBMITTED ON THREE SEPARATE REGULATORY REPORTS (MEDTRONIC INTERNAL REFERENCE NUMBERS: (B)(4). THE REGULATORY REPORT NUMBERS WERE NOT AVAILABLE AT THE TIME OF SUBMISSION.). THERE WAS NO INJURY REPORTED AS A RESULT OF EACH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703772 MICROFRANCE® INSTRUMENT LOOP, WIRE JYQ XOMED MICROFRANCE MFG 7718 130902

    Patients

    Seq Age Sex Outcome Treatment
    1