BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE F/MONOPOLAR ELECTRODES 5MM

    MDR report key: 5554676 · Received April 7, 2016

    Report

    Report Number
    2916714-2016-00254
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Report Date
    May 2, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018 MANUFACTURING SITE EVALUATION: ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: FRANCE SLIGHT BURN REQUIRING NO CARE AFTER CONSULTATION WITH A PLASTIC SURGEON. INVOLVED COMPONENTS: GK372R / HANDLE F/MONOPOLAR ELECTRODES GK384R / CERAMIC ELECTRODE TIP L-HK F/GK372R GK370P / SHAFT ONLY F/MODULAR MONOPOL.ELECTR

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE INSTRUMENT WAS ANALYZED USING A KEYENCE VHX 5000 DIGITAL MICROSCOPE. THE COLLET AT THE DISTAL END OF THE SHAFT IS BENT AND THE TIP OF THE ELECTRODE IS TWISTED. ALSO THE TUBE IS NOT FIXED TO THE PROXIMAL END OF THE SHAFT. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: ALL THE PARTS OF THE INSTRUMENT SHOW SIGNS OF WEAR AND TEAR. THE BENT COLLET AND THE TWISTED ELECTRODE ARE MOST LIKELY CAUSED DUE TO OVERLOAD. THE "SAFE HANDLING AND PREPARATION" ARE STATED IN THE IFU. DESPITE THE DAMAGES, THE PRODUCT IS STILL WORKING. IT IS POSSIBLE THAT AN UNINTENTIONAL BURN IS CAUSED BY A HEATED ELECTRODE IMMEDIATELY AFTER THE PREVIOUS APPLICATION. THEREFORE THE INJURY IS MOST LIKELY CAUSED BY AN IMPROPER HANDLING OF THE INSTRUMENT. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215143 HANDLE F/MONOPOLAR ELECTRODES 5MM HANDPIECE GEI AESCULAP AG GK372R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other