BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM

    MDR report key: 5474421 · Received March 2, 2016

    Report

    Report Number
    2916714-2016-00150
    Event Type
    Injury
    Date Received
    March 2, 2016
    Report Date
    May 25, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K151696
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: (B)(6). CAIMAN INSTRUMENT DID NOT SEAL TISSUE DURING SURGERY, WHICH RESULTED IN BLEEDING. USE OF VASCULAR CLIPS WAS NEEDED.

    Additional Manufacturer Narrative · 1

    THE RECEIVED INSTRUMENT ARRIVED CLEAN AND WITHOUT VISIBLE DAMAGE. TEST AND ANALYSIS EQUIPMENT USED: AESCULAP RF- GENERATOR "GN 200", SNR. (B)(4). MICROSCOPE "(B)(4)- VHX 5000." DIGITAL-CAMERA "(B)(4) DMC TZ8." FLUKE TRMS- MULTIMETER, TD NO. 1838. DISTANCE GAUGE. MEASURING MODULE BOX WITH POWER SUPPLY. VISIBLE INSPECTION OF THE JAW INDICATED NO ABNORMITIES SUCH AS BURNED OR CHARRED AREAS. MECHANICAL FUNCTION WAS TESTED, THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. THE INSTRUMENT WAS CONNECTED TO AN RF- GENERATOR "GN 200", SERIAL NO.(B)(4), AND ELECTRICAL FUNCTIONS WERE TESTED, RESULTS ARE: TEST STEP: GENERATOR- ANNOUNCEMENT: RESULT: ACTIVATION WITH OPEN JAW, "REGRASP OPEN" , O.K. ACTIVATION WITH WET TISSUE, "SEALING", O.K. ACTIVATION WITH CLOSED JAW, "REGRASP SHORT", O.K. ACTIVATION WITH TIN-FOIL IN JAW, "REGRASP SHORT", O.K. THE FUNCTION OF THE RESISTANCE OF THE SYSTEM WAS TESTED AND FOUND TO BE WITHIN SPECIFICATION. THE INSTRUMENT WAS DECONTAMINATED FOR THE REMAINDER OF THE INVESTIGATION. THE DEVICE WAS MICROSCOPICALLY INSPECTED AND THERE WAS NO DAMAGE, SUCH AS CHARRING, IMPACTS OR DAMAGED DISSECTION CLIP NOTED. THE CLEARANCE BETWEEN THE UPPER AND LOWER JAW WAS FOUND TO BE WITHIN SPECIFICATION. MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. BECAUSE THE CAIMAN SYSTEM IS VALIDATED, AND THE COMPLAINED INSTRUMENT IS WITHOUT ANY DEVIATION TO THE FUNCTION RELEVANT PARAMETERS, THE ROOT CAUSE IS MOST PROBABLY USER RELATED. CORRECTIVE / PREVENTIVE ACTION: NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130840 CAIMAN DISP.INSTR.NON ARTICUL.D5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL740SU 52164660

    Patients

    Seq Age Sex Outcome Treatment
    1 Other