BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL.D:5/240MM

    MDR report key: 6183094 · Received December 16, 2016

    Report

    Report Number
    9610612-2016-00004
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    September 22, 2016
    Report Date
    December 16, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS GRASPING THE TISSUE THE DEVICE STARTED SPARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833546 CAIMAN DISP.INSTR.NON ARTICUL.D:5/240MM ENDOSCOPY GEI AESCULAP AG PL718SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other