BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5193988 · Received November 1, 2015

    Report

    Report Number
    2916714-2015-00992
    Event Type
    Malfunction
    Date Received
    November 1, 2015
    Report Date
    October 30, 2015
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    SEE NARRATIV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): K110824 / K130596. MANUFACTURING SITE EVALUATION: ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). ELECTIVE SLEEVE GASTRECTOMY ON MALE PATIENT; MODERATELY OBESE BUT NOT SEVERE. THE SURGEON STARTED DISSECTION OF THE OMENTUM. AFTER THE FIRST "SEAL AND CUT" A LARGE BLEED OCCURRED. BLOOD VESSEL ESTIMATED TO BE AT 3-4MM. STEAM WAS GIVEN OFF BY THE DEVICE; SURGEON TRIED REPEATEDLY TO SEAL BUT WITH NO SUCCESS. DEVICE WAS DISCARDED AND VESSEL WAS SEALED WITH A LIGATION CLIP. SURGEON WAS PROVIDED A 2ND CAIMAN HAND PIECE; RESULTS IMPROVED AND THE SURGEON COMPLETED CASE. GENERATOR IN USE DURING PROCEDURE IS GN200 / LEKTRAFUSE HF GENERATOR BIPOLAR SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724327 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL720SU 52130344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other