BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 3913370 · Received July 3, 2014

    Report

    Report Number
    9680837-2014-00051
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GCJ
    PMA / PMN Number
    K080257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT ANALYSIS DETERMINED THAT THE WIRE INSIDE THE FORCEPS IS BROKEN. SOME TORSION MARKS ARE VISIBLE ON THIS WIRE. THERE IS NO FRAGMENT MISSING. THE FORCEPS IS GLOBALLY DETERIORATED. THE MONOPOLAR PIN IS BROKEN AND MISSING. HOWEVER, THIS PART IS NOT IN PATIENT CONTACT, THE RISK IS VERY LOW. THE RUPTURE OF THE WIRE IS IN ALL LIKELIHOOD LINKED TO THE WEAR OF THE FORCEPS, WITH AN IMPORTANT USE IN TORSION. THE GENERAL DETERIORATION OF THE INSTRUMENT IS DUE TO ITS AGE (11 YEARS). THE MONOPOLAR PIN PROBABLY BROKE BECAUSE OF A FALL OR AN EXCESSIVE EFFORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A BROKEN AND MISSING PIN, IN AN AREA THAT WOULD BE PROXIMAL TO THE PATIENT AND SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390390 MICROFRANCE® INSTRUMENT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ XOMED MICROFRANCE MFG CEV525M 200303MF

    Patients

    Seq Age Sex Outcome Treatment
    1