BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4120807 · Received July 28, 2014

    Report

    Report Number
    2916714-2014-00581
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 28, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K122734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K): K093075/K130596. US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MFG SITE EVALUATION: VISUAL INSPECTION: THE INSTRUMENT ARRIVED HEAVILY CONTAMINATED. THE SURFACE OF THE ELECTRODES WERE CONTAMINATED WITH DRIED AND SCORCHED BLOOD, MAYBE WITH RESTS OF TISSUE. ONE OF THE STEERING WIRES WAS HANGING OUT OF THE GUIDE. THIS DETAILS WAS NOT PROVIDED IN THE EVENT DESCRIPTION, AND MAY HAVE OCCURRED DURING SHIPMENT TO MFG SITE. ELECTRICAL AND MECHANICAL PARAMETERS WERE CHECKED: THE MEASURING OF THE CLAMP FORCE SHOWS NO ABNORMALITIES. THE OTHER MECHANICAL FUNCTIONS, WITH THE EXCEPTION OF THE GUIDE WIRES, ARE ALL ACCORDING TO SPECIFICATION. FURTHER TESTING PERFORMED FOLLOWING DECONTAMINATION: ELECTRICAL RESISTANCE OF EACH SINGLE JUNCTION BETWEEN PLUG AND THE TONGUES IN THE JAW WAS TESTED AND FOUND TO BE LOWER THAN 1 OHM (SPEC.: (B)(4)) AND THEREFORE TESTED AS ACCEPTABLE. THE RESISTANCE OF THE ACTIVATOR CIRCUIT IS LOWER THAN 2 OHM (SPEC. (B)(4)), THEREFORE TESTED ACCEPTABLE. CHECKING GAP (CLOSED YAW): 0, 25 MM (SPEC: (B)(4)) THIS IS ALSO ACCEPTABLE. RESULT: THE ELECTRICAL AND MECHANICAL PARAMETERS ARE ALL ACCORDING TO SPECIFICATION. IT SHOULD BE NOTED THAT THE ELECTRODE SURFACE MUST BE CLEANED AT ALL TIMES DURING SURGERY, TO PREVENT CARBONIZATION, WHICH LEADS TO A LOSS OF SEALING PERFORMANCE. CONCLUSION: ALL RESULTS INDICATE A USER RELATED ERROR, THERE NO INDICATIONS OF A PRODUCT FAULT OR MATERIAL DEFECT. THERE ARE CURRENTLY NO FURTHER COMPLAINTS WITH BATCH S136 AT HAND.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PT WAS MORBIDLY OBESE, WITH BMI IN EXCESS OF (B)(6). SURGEON CREATED A WINDOW IN THE OMENTUM, AND INTRODUCED THE PL731SU CAIMAN HANDPIECE TO INITIATE THE DEVASCULARISATION OF THE STOMACH, AND APPLIED THE FIRST SEAL. ALL APPEARED TO BE OK, HOWEVER THE SEAL THEN BEGAN TO OOZE PERSISTENTLY. SURGEON DEALT WITH THIS BLEEDING USING A MONOPOLAR DIATHERMY HOOK. ADDITIONAL SEALS WERE APPLIED, AGAIN WITH OOZING FROM THE SEALS. SURGEON THEN ADOPTED A TECHNIQUE OF "DOUBLE SEALING", APPLYING THE FIRST SEAL ON THE OMENTUM, AND THEN APPLYING THE SECOND SEAL TO THE LEFT OF THE INITIAL SEAL, ON THE STOMACH SIDE. AFTER THE INITIAL "DOUBLE SEAL", IT WAS NOTED THAT ON CLOSING THE JAWS OF THE INSTRUMENT, PRIOR TO THE SECOND SEAL THE FIRST SEAL WOULD OPEN, INDICATING THAT THE FIRST SEAL HAD FAILED. THIS CONTINUED FOR ABOUT 50% OF THE PROCEDURE. IT WAS DECIDED TO USE A LIGASURE ATLAS, TO ENSURE THAT THERE WAS NOT PT CIRCUMSTANCE ATTRIBUTING TO THE ISSUE. THE LIGASURE DEVICE WORKED SEAMLESSLY WITH A VERY HIGH QUAL TISSUE SEAL, WITH NO BLEEDING. THE LIGASURE ATLAS WAS NOT LONG ENOUGH, HOWEVER, TO REACH THE TOP OF THE STOMACH, SURGEON ELECTED TO USE THE CAIMAN AGAIN, DUE TO THE LONGER SHAFT AND JAW. HE AGAIN APPLIED A "DOUBLE SEAL", AND IMMEDIATELY ON RELEASING THE JAWS AFTER THE SECOND SEAL, AND CUTTING THE TISSUES, THERE WAS AN ARTERIAL BLEED WHICH NEEDED TO BE SEALED, AND THIS WAS ACHIEVED WITH THE CAIMAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440017 CAIMAN DISP. INSTR. ARTICULAT. D.: 12/440MM TISSUE CUTTING, SEALING DEVICE GEI AESCULAP AG & CO. KG PL731SU S136

    Patients

    Seq Age Sex Outcome Treatment
    1 Other