BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4291144 · Received December 2, 2014

    Report

    Report Number
    9680837-2014-00104
    Event Type
    Malfunction
    Date Received
    December 2, 2014
    Report Date
    November 7, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): TUBE CEV649-5B DIA 5MM 310MM, LOT 131209 MANUFACTURED DECEMBER 2013. (B)(4): PRODUCT EVALUATION: ANALYSIS FOR CEV649-5B, LOT 120715, FOUND THAT THE TUBE HAD ITS PROXIMAL PARTS UNSCREWED. THE INTEGRITY OF THE ELECTRICAL INSULATION IS COMPROMISED BUT THE DAMAGES ARE EASILY OBSERVABLE, THE RISK FOR THE PATIENT IS LIMITED. NUMEROUS IMPACTS ARE OBSERVABLE ON THE TUBE. ELECTRICAL TESTS FAILED. ANALYSIS FOR CEV649-5B, LOT 131209, FOUND THAT THE TUBE HAS A DAMAGED SHEATH AND IS BENT. THE INTEGRITY OF THE ELECTRICAL INSULATION IS COMPROMISED BUT THE DAMAGES ARE EASILY OBSERVABLE, THE RISK FOR THE PATIENT IS LIMITED. NUMEROUS IMPACTS ARE OBSERVABLE ON THE TUBE. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND. ELECTRICAL TESTS FAILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿BLACK SHEATHS ARE TOO SHORT¿. THERE WAS NO REPORTED PATIENT IMPACT. ANALYSIS FOUND THAT THE INTEGRITY OF THEIR INSULATION IS COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778035 MICROFRANCE® INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV649-5B 120715

    Patients

    Seq Age Sex Outcome Treatment
    1