BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP. INSTR. ARTICULAT. D:12/240MM

    MDR report key: 4270110 · Received November 11, 2014

    Report

    Report Number
    2916714-2014-00812
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    September 16, 2014
    Report Date
    November 7, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K093075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) K130596. MFG SITE EVAL: EVAL ON-GOING AT MFG SITE.

    Description of Event or Problem · 1

    OPEN HYSTERECTOMY. TWO CASES (BACK TO BACK) ON (B)(6) 2014. SURGEON REPORTED SAME ISSUE OCCURRED IN EACH CASE. DEVICE WAS NOT SEALING; RE-GRASP ALARM. UNABLE TO SEAL. DR ASKED TO CLEAN THE DEVICE; IT WAS CLEAN AND DRY. DEVICE STILL ALARMED. IN EACH CASE, DR OPENED ANOTHER DEVICE WHICH THEN FUNCTIONED AS INTENDED. SURGERIES WERE COMPLETED AS EXPECTED. EACH CASE EXPERIENCE AN APPROXIMATE FIVE MINUTE SURGICAL DELAY TO RETRIEVE ANOTHER DEVICE. NO PT INJURIES. FIRST REPORTED UNDER MEDWATCH # 2916714-2014-00811.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724933 CAIMAN DISP. INSTR. ARTICULAT. D:12/240MM CUT AND SEAL INSTRUMENT GEI AESCULAP AG AND CO. KG PL730SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other