BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM

    MDR report key: 5011562 · Received August 12, 2015

    Report

    Report Number
    2916714-2015-00695
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    August 10, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K110824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510 (K): K130596. EVAL ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). INSTRUMENT STOPS DURING USE. SURGICAL DELAY OF 15 MINUTES, NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530615 CAIMAN DISP. INSTR. NON ARTICUL. D:5/360MM CVT AND SEAL DEVICE GEI AESCULAP AG & CO. KG PL720SU 52122764

    Patients

    Seq Age Sex Outcome Treatment
    1 Other