BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP INSTR NON ARTICUL D:5/360MM

    MDR report key: 3805245 · Received April 16, 2014

    Report

    Report Number
    2916714-2014-00246
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 16, 2014
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    K1110824 / K130596. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVAL: THE INSTRUMENT ARRIVED UNPACKED AND WITH A CUT OFF CONNECTION CABLE. THE CLEAN STATUS LEADS TO THE ASSUMPTION, THAT THE INSTRUMENT WAS DECONTAMINATED AT THE HOSP. ELECTRICAL INSPECTION: BEFORE THE ELECTRICAL INSPECTION IT WAS NECESSARY TO JOIN THE CABLE AGAIN (SOLDERING AND SHRINKING HOSES). THE ELECTRICAL RESISTANCE OF THE COMPLETE INSTRUMENT WAS THEN CHECKED. FOR THIS PURPOSE WE CLAMPED A PIECE OF TIN FOIL IN THE JAW, AND MEASURED THE UPPER AND THE LOWER LINK IN COMMON. RESULT OF THE MEASURING: IN THE REST POSITION, THE RESISTANCE IS ACCORDING TO SPECIFICATION (LOWER THAN 5 OHM). DURING HANDLING AND BENDING THE SHAFT, THE RESISTANCE CHANGES (PERMANENT), EVEN TO VALUES OUT OF SPEC. THIS BEHAVIOR IS UNUSUAL. OPENING THE HANDLE FOR INVESTIGATION: AFTER OPENING THE HANDLE, WE INVESTIGATED THE SLIDING CONTACT WAS ACCORDING TO SPEC BUT THE DISTAL ONE EXHIBITS GAPS BETWEEN THE SHAFT. THE SHAFT IS THE LINK FOR THE LOWER ELECTRODE OF THE JAW. THIS IS ONE OF THE POSSIBLE REASONS FOR THE CHANGES IN RESISTANCE. DUE TO THE INSTRUMENT BEING CLEANED, IT IS NOT POSSIBLE TO ANALYZE IF IT HAD A PROBLEM WITH CONTAMINATION ON THE CONTACT SURFACE. MFG DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPEC AT THE TIME OF PRODUCTION. DUE TO CONDITION OF DEVICE CAUSE OF FAILURE CAN NOT BE DETERMINED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THE HANDPIECE WAS NOT SEALING TISSUE INSIDE THE PT BUT WOULD SEAR A SWAB OUTSIDE. THE DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE. THE JAWS WERE CLAMPED AROUND TISSUE AND THE ACTIVATION BUTTON PRESSED, THE CYCLE RAN, BUT WAS VERY BRIEF. THE CYCLE SHOWED THAT IT HAD ENDED AS NORMAL. THE TISSUE THAT HAD BEEN GRASPED HAD ONLY SLIGHTLY CHANGED IN COLOR AND WHEN CUT IT BLED. SEVERAL ADDITIONAL ATTEMPTS HAD THE SAME RESULTS. THE JAWS WERE INSPECTED AND CLEANED, BUT THIS DID NOT MAKE A DIFFERENCE. THE DEVICE WAS THEN CLAMPED ON A WET SWAB OUTSIDE OF THE PT AND THE ACTIVATION BUTTON PRESSED. ON THIS OCCASION, THE DEVICE RAN FOR A LONGER TIME, THE DEVICE HISSED AND STEAM WAS PRODUCED SUGGESTING THAT IT WAS WORKING FINE. IT WAS TRIED AGAIN IN THE PT BUT THE DEVICE STILL DID NOT SUCCESSFULLY RUN ON THE PT TISSUE. THE GENERATOR WAS TURNED OFF AND ON AND THE HANDPIECE UNPLUGGED AND PLUGGED IN NEITHER OF THESE MADE ANY DIFFERENCE. GENERATOR WAS USED IN DIFFERENT PROCEDURE WITH DIFFERENT SURGEON USING PL720SU OF SAME BATCH WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233428 CAIMAN DISP INSTR NON ARTICUL D:5/360MM SEAL & CUT INSTRUMENTS GEI AESCULAP AG & CO KG PL720SU 51953148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other