BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM]

    MDR report key: 3413166 · Received October 16, 2013

    Report

    Report Number
    9680837-2013-00481
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 2, 2013
    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

    CONCOMITANT: BIPOLAR INSERT CEV634-1A 350MM MOUIEL IS BEING REPORTED AS A CONCOMINANT PRODUCT. SERIAL # - NOT APPLICABLE ; LOT# - 121007 ; MANUFACTURE DATE- OCTOBER 2012; 510K# - K993655. EVALUATION SUMMARY: THE FINDINGS OF THE PRODUCT ANALYSIS DETERMINED THAT ON TUBE CEV649-5B DIA 5MM 350MM ¿THE SCREW THREAD IS BROKEN. THE MISSING FRAGMENT OF SCREW THREAD WAS NOT RETURNED, BUT THE RISK OF FRAGMENT IN PATIENT BODY IS UNLIKELY CONSIDERING THAT THE MISSING PART IS SCREWED ON AN INSERT. THE OBSERVATION OF THE INSULATION HAS HIGHLIGHTED SOME TRACES OF GRIPPING WITH PLIERS. HOWEVER THE ELECTRICAL TESTS CONFORM AND THE ELECTRICAL INTEGRITY IS NOT COMPROMISED.¿ DEVICE ANALYSIS ON BIPOLAR INSERT CEV634-1A 350MM MOUIEL DETERMINED THAT ¿THE ELECTRODE TUBE PRESENTS A CRACK AND A BLISTER. THE FORMATION OF THE BLISTER IS DUE TO THE PRESSURE OF THE GLUE ON A PRE-EXISTING CRACK ON THE TUBE DURING THE STERILIZATION CYCLES.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED "1 SHEATH: BROKEN SCREW THREAD/1 BIPOLAR INSERT: HERNIA ON THE TUBE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530957 TUBE CEV649-5B DIA 5MM 350MM [MXI/XOM] ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV649-5B 130710

    Patients

    Seq Age Sex Outcome Treatment
    1