BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1831448 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08536
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    November 30, 2007
    Report Date
    December 1, 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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, THE PORT SEEMED TO BE LEAKING FROM THE IRIS VALVE. INSUFFLATION COULD NOT BE MAINTAINED AND HAD TO BE SET TO A HIGHER PRESSURE TO GET TO A PRESSURE THAT WOULD MAINTAIN PNEUMOPERITONEUM. THE PRESSURE WAS NEVER STEADY THROUGHOUT THE PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1