BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM

    MDR report key: 6425685 · Received March 22, 2017

    Report

    Report Number
    9610612-2017-00180
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Report Date
    June 29, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K093075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: SWEDEN. IT WAS REPORTED THAT TWO SURGERIES WITH TWO DIFFERENT DOGS WAS PERFORMED. BOTH ANIMALS SUFFERED FROM BLEEDING BECAUSE COAGULATION WAS INSUFFICIENT. A LIFE-THREATENING SITUATION OCCURRED WITH BOTH ANIMALS AND FINALLY ONE DOG DIED. REPORTS RELATED TO THESE INCIDENTS INCLUDE: 9610612-2017-00181. COMPONENTS IN USE LISTED AS CONCOMITANT DEVICES ARE: PL731SU / CAIMEN DISP.INSTR.ARTICULAT.D:12/440MM. GN200 / LERTRAFUSE HF GENERATOR BIPOLAR.

    Additional Manufacturer Narrative · 1

    INVESTIGATION USED TEST AND ANALYSIS EQUIPMENT: -AESCULAP RF- GENERATOR "GN 200", SNR. (B)(4). -MICROSCOPE "KEYENCE- VHX 5000 D". -DIGITAL-CAMERA "PANASONIC DMC TZ8. -FLUKE 178 TRMS MULTIMETER .-MEASURING MODULE BOX WITH POWER SUPPLY. FIRST WE MADE A VISIBLE INSPECTION OF THE JAW. HERE WE FOUND NO ABNORMITIES LIKE BURNED OR CHARRED PEAK. THEN WE CHECKED THE MECHANICAL FUNCTION. THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. IN THE NEXT STEP WE CONNECTED THE INSTRUMENT WITH AN RF- GENERATOR "GN 200", SNR.(B)(4), AND CHECKED THE ELECTRICAL FUNCTIONS RESULT: IT WAS NOT ABLE TO START THE SEALING PROCESS WITH THE TRIGGER BUTTON. BATCH HISTORY REVIEW THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE THE ROOT CAUSE FOR THE PROBLEM IS USER RELATED. RATIONAL THE RESTERILISATION BY INSERTION IN A LIQUID CAUSED OXIDATION AT THE SURFACE OF THE TRIGGER SWITCH. ELECTRIC / ELECTRONICAL EQUIPMENT WITH OPEN CONTACT SYSTEMS ARE NOT SUITABLE FOR INSERTION IN LIQUIDS OR SOLUTIONS. CAIMAN RF SEAL AND CUT INSTRUMENTS ARE RADIATION- OR RATHER ETHYLENE STERILIZED INSTRUMENTS AND NOT SUITABLE FOR RESTERILISATION. CORRECTIVE ACTION ACCORDING TO SA-DE13-M-4-2-01-010-0, A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206155 CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM ENDOSCOPY GEI AESCULAP AG PL731SU S373R

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GN200 / LEKTRAFUSE HF GENERATOR BIPOLA| PL731SU / CAIMEN DISP.INSTR.ARTICULAT.D:12/440MM| GN200 / LEKTRAFUSE HF GENERATOR BIPOLA