BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR 12 MM DIAMETER, 100 MM LENGT

    MDR report key: 1822220 · Received December 3, 2007

    Report

    Report Number
    1527736-2007-08211
    Event Type
    Malfunction
    Date Received
    December 3, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 26, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE OPERATING THE DR FOUND OUT THAT AIR WAS SLIPPING OUT FROM ONE OF THE TROCARS. THEY FOUND THAT ONE OF THE INNER PIECES OF THE SEAL WAS MISSING. AFTER A WHILE THEY FOUND IT IN THE PT. COMPLETED WITH THE SAME LIKE PRODUCT. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH XCEL STABILITY SLEEVE FOR BLADELESS TROCAR 12 MM DIAMETER, 100 MM LENGT GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1