BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3810496 · Received April 15, 2014

    Report

    Report Number
    2916714-2014-00240
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    K1110824 / K130596. MANUFACTURING SITE EVALUATION: VISUAL AND MECHANICAL: INSTRUMENT ARRIVED UNPACKED. WITH THE FIRST VIEW WE SAW THAT THE INSTRUMENT WAS CLEAN. WE ASSUME THAT THE INSTRUMENT WAS DECONTAMINATED AT THE HOSPITAL. THE CAIMAN SHOWS NO DAMAGES OR MECHANICAL ABNORMALITIES. ELECTRICAL INSPECTION: THE ELECTRICAL PARAMETERS ARE ACCORDING TO THE SPECIFICATION. THE RESISTANCE OF BOTH PATHS (LOWER AND UPPER JAW) ARE LOWER THAN FOUR OHM. EVEN UNDER BENDING STRESS THE RESISTANCE WOULDN'T INCREASE, THIS IS AN INDICATION FOR PROPER SLIDING CONTACTS. OPENING THE HANDLE FOR INVESTIGATION: AFTER OPENING THE HANDLE, WE INVESTIGATED THE SLIDING CONTACTS. PROXIMAL AND DISTAL CONTACTS ARE ACCORDING TO SPECIFICATION, THE CONTACT SURFACES WERE CLEAN. CONCLUSION: ALL IMPORTANT PARAMETERS ARE WITHIN SPECIFICATION THERE ARE NO HINTS FOR A MALFUNCTION. CAIMAN - INSTRUMENTS SHOULDN'T BE DECONTAMINATED PRIOR TO ANALYSES, IF SO, SOME DEFECTS, E.G. CAUSED BY SOILED CONTACT SURFACES, COULDN'T BE REPRODUCED. UNABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING CONDUCTING A TRIAL THERE WAS A BLEED WITH THE USE OF CAIMAN. THE SURGEON WAS AN EXISTING HARMONIC USER. THE CASE WAS A SLEEVE GASTRECTOMY. FROM THE OUTSET, WHEN ACTIVATED THE CYCLE SEEMED VERY SHORT BUT WAS RUNNING A FULL CYCLE AS EXPECTED. EVEN WHEN CUTTING FAT AND SMALL VESSELS, THE TISSUE WAS NOT SEALED AND BLED PROFUSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230566 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM SEAL & CUT INSTRUMENT GEI AESCULAP AG & CO. KG PL720SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other