BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK CEV390C DIA 3.5MM 330MM MONOPOLAR

    MDR report key: 3607397 · Received February 5, 2014

    Report

    Report Number
    9680837-2014-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 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

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: HOOK CEV390B DIA 3.5MM 330MM MONOPOLAR, 510K: K993655, LOT# 110103, MFR DATE JAN. 2011. DISSECTOR INSERT CEV398I 310MM DIA35, 510K: K993655, LOT# 130401, MFR DATE APR. 2013. SCISSORS INSERT CEV393I 310MM SERRATED, 510K: K993655, LOT# 130303, MFR DATE MAR. 2013. FENESTRATED INSERT CEV395I 310MM DIA35, 510K: K993655, LOT# 130303, MFR DATE MAR. 2013. (B)(4). THE PRODUCT ANALYSIS DETERMINED THAT: HOOK CEV390B DIA 3.5MM 330MM MONOPOLAR- ¿THE COATING SHRUNK IN LENGTH ON THE PROXIMAL PART OF THE INSTRUMENT. THE INSULATION DEFECT IS LOCATED ON THE PROXIMAL END OF THE DEVICE AND THE RISK OF ELECTRICAL INJURIES IS REMOTE.¿ HOOK CEV390C DIA 3.5MM 330MM MONOPOLAR- ¿THE COATING SHRUNK IN LENGTH ON THE DISTAL PART OF THE INSTRUMENT. THE DEFECT IS EASILY OBSERVABLE AND THE INSTRUMENT WAS PROBABLY NOT USED IN THIS CONDITION.¿ DISSECTOR INSERT CEV398I 310MM DIA35- ¿THE COATING SHRUNK IN LENGTH ON THE PROXIMAL PART OF THE INSTRUMENT. THE INSULATION DEFECT IS LOCATED ON THE PROXIMAL END OF THE DEVICE AND THE RISK OF ELECTRICAL INJURIES IS REMOTE.¿ SCISSORS INSERT CEV393I 310MM SERRATED- ¿THE COATING SHRUNK IN LENGTH ON THE DISTAL PART OF THE INSTRUMENT. THE DEFECT IS EASILY OBSERVABLE AND THE INSTRUMENT WAS PROBABLY NOT USED IN THIS CONDITION.¿ FENESTRATED INSERT CEV395I 310MM DIA35- ¿THE COATING SHRUNK IN LENGTH ON THE PROXIMAL PART OF THE INSTRUMENT. THE INSULATION DEFECT IS LOCATED ON THE PROXIMAL END OF THE DEVICE AND THE RISK OF ELECTRICAL INJURIES IS REMOTE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SALES REP RETURNED HIS INSTRUMENTS FOR REPAIR. THE REPAIR REPORT INDICATED A BREACH OF INSULATION IN THE ELECTROCAUTERY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75833 HOOK CEV390C DIA 3.5MM 330MM MONOPOLAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV390C 130401

    Patients

    Seq Age Sex Outcome Treatment
    1