BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR SLEEVE

    MDR report key: 1862203 · Received October 4, 2010

    Report

    Report Number
    1862203
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS A (B)(6) FEMALE, ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2010 FOR A SCHEDULED GALLBLADDER SURGERY. THE SURGEON REPORTED THAT ONE OF THE REPROCESSED 5MM TROCAR SLEEVES LEAKED. THE SURGEON ADVISED THAT HE HAS HAD MULTIPLE ISSUES WITH THE REPROCESSED ASCENT TROCAR SLEEVES. THE SLEEVE HAS A CONNECTOR PORT WHERE A GAS LINE IS CONNECTED. THE GAS IS USED TO INFLATE THE ABDOMEN IN ORDER TO HELP FACILITATE THE SURGICAL PROCESS. AT THE TOP OF THE TROCAR SLEEVE IS A SEAL, AND IT IS THIS SEAL THAT IS LEAKING THUS ALLOWING THE GAS TO ESCAPE FROM THE ABDOMEN. THE SURGEON ADVISED THAT WHEN THIS HAPPENS THE PROCEDURE IS STOPPED UNTIL ANOTHER TROCAR SLEEVE CAN BE INSERTED. THE SURGEON ALSO REPORTED THAT HE HAS ENCOUNTERED THIS PROBLEM MORE THAN ONCE DURING THE SAME PROCEDURE. THE SURGEON CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCAR SLEEVE XCEL TROCAR SLEEVE GCJ ETHICON ENDO-SURGERY, INC. CB5LT 1227940

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other