BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAIMAN DISP. INSTR. ARTICULAR D-12/240MM

    MDR report key: 3829803 · Received May 6, 2014

    Report

    Report Number
    2916714-2014-00319
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K093075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510(K): K130596. EVAL: WAITING FOR PRODUCT RETURN.

    Description of Event or Problem · 1

    OPEN COLECTOMY. CAIMAN VESSEL SEALING DEVICE WOULD NOT SEAL. SURGEON CONTINUOUSLY DOUBLE SEALED AND WHEN HE WOULD CUT TISSUE IT WOULD BLEED. NO PT INJURY. SURGICAL DELAY LESS THAN 30 MINUTES. SUTURE AND A STAPLER WAS REQUIRED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270861 CAIMAN DISP. INSTR. ARTICULAR D-12/240MM SEAL AND CUT INSTRUMENT GEI AESCULAP AG & CO. KG PL730SU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other