BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4644048 · Received March 31, 2015

    Report

    Report Number
    9680837-2015-00028
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Report Date
    March 5, 2015
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: KNIFE MCL59 BAYONET MONOPOLAR FRECHE, 510K: K993655, LOT# 140903, MFR DATE: SEPTEMBER 2014. (B)(4). THE PRODUCT ANALYSIS FOR FORCEPS MCO13C ALLIGATOR 3X0.6MM HARTMAN FOUND THAT ¿ONE OF THE PINS OF THE ACTIVE PART IS BROKEN. THERE IS NO SIGN OF MANUFACTURING OR MATERIAL DEFECT. THE FRAGMENTS OF THE PINS ARE STILL ON THE INSTRUMENT AND SO THERE IS NO RISK FOR THE PATIENT. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS AN IMPACT OR EXCESSIVE FORCE DURING THE USES OR THE REPROCESSING OF THE INSTRUMENT.¿ THE PRODUCT ANALYSIS FOR KNIFE MCL59 BAYONET MONOPOLAR FRECHE, FOUND THAT ¿THE ACTIVE PART IS BROKEN AND MISSING. HOWEVER, THE EVENT IS MOST LIKELY TO HAVE OCCURRED DURING THE REPROCESSING. MOREOVER, THE FRAGMENT IS 25MM LONG AND COULD NOT HAVE BEEN LEFT UNNOTICED. NO MANUFACTURING OR MATERIAL DEFECT WAS FOUND.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANALYSIS WAS REQUESTED FOR ¿TWO INSTRUMENTS THAT BROKE QUICKLY AFTER THEIR FIRST USES". THE ANALYSIS SHOWED THAT THE BREAK CREATED FRAGMENTS. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211722 MICROFRANCE® INSTRUMENT FORCEPS, ENT KAE XOMED MICROFRANCE MFG MCO13C 150105

    Patients

    Seq Age Sex Outcome Treatment
    1