BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5442691 · Received February 17, 2016

    Report

    Report Number
    2916714-2016-00097
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    May 25, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. PRIOR 510(K): K110824. MANUFACTURING SITE EVALUATION: ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). CAIMAN MALFUNCTIONED DURING USE. DURING A RADICAL PROSTATECTOMY, THE DEVICE STOPPED WORKING; THERE WAS AN ERROR MESSAGE ON THE CONSOLE: "REGRASP INDICATOR SHORT-VISUALLY CHECK SEAL-MANUALLY CUT-CHECK FOR METAL OR OCCLUSION IN JAW-REMOVE EXCESS FLUIDS". THE SURGEON CHANGED THE CAIMAN AND THE SECOND CAIMAN DID NOT PERFORMED COAGULATION AFTER CUTTING. THIS WAS FOLLOWED BY A LARGE HEMORRHAGE (800ML OF BLOOD, QUICKLY).

    Additional Manufacturer Narrative · 1

    THE RECEIVED DEVICE WAS FOUND TO BE MISSING THE ROCKER UNDER THE JAW. TEST AND ANALYSIS EQUIPMENT USED: MICROSCOPE "KEYENCE- VHX 600 D", DIGITAL-CAMERA "PANASONIC DMC TZ8. VISIBLE INSPECTION OF THE JAW WAS COMPLETED AND EXCEPT THE BLOOD SOILING AN THE ABSENT ROCKER, NO OTHER ABNORMITIES WERE NOTED. MECHANICAL FUNCTION TESTS INDICATED THE CLAMPING AND THE CUTTING FUNCTION WORKED WELL. THE DEVICE WAS DECONTAMINATED AND MICROSCOPIC INSPECTION OF THE JAW WAS COMPLETED. IT WAS NOTED THAT UNDER THE JAW THERE IS AN IMPERFECT NOTCH. THE NOTCH IS NECESSARY TO FIX THE JUNCTION PIN IN ITS POSITION. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THE ASSEMBLY RESULTED IN AN IMPERFECT CRIMPING AFTER INSERTING THE ROCKER, WHICH RESULTED IN THE ROCKER BACKING OUT. CORRECTIVE ACTION IS NECESSARY AND HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98706 CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM CUT AND SEAL DEVICE GEI AESCULAP AG PL720SU 52172733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other