BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR SLEEVE

    MDR report key: 1901385 · Received November 11, 2010

    Report

    Report Number
    1901385
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 4, 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 PT IS A (B)(6) FEMALE WHO IS POST LAPAROSCOPIC GASTRIC BYPASS COMPLETED IN (B)(6) 2008. IN (B)(6) OF 2009, SHE UNDERWENT A LAPAROSCOPIC INTERNAL HERNIA REPAIR. SHE CONTINUED TO HAVE SOME ABDOMINAL PAIN WHICH AT TIMES WOULD BE SEVERE. SHE HAD A FULL WORK UP AND ON (B)(6) 2010, THE SURGEON PRECEDED WITH A LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE PROCEDURE, THE SURGEON NOTICED THAT GAS WAS LEAKING AROUND THE VALUE OF ONE OF THE TROCARS. THE SURGEON DID NOT REMOVE THE TROCAR. HE WRAPPED IT SO IT WOULD REMAIN AIR TIGHT AND COMPLETED THE PROCEDURE. THE TROCAR WAS LEAKING AT THE FUNNEL VALVE. THE TROCAR WAS DISPOSED OF AFTER THE PROCEDURE. THERE WAS NO HARM TO THE PT. THE SURGEON REPORTED THAT THE TROCAR WAS A REPROCESSED TROCAR AND BELIEVES THAT THE DEVICES ARE MORE PRONE TO LEAKS AFTER THEY ARE REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCAR SLEEVE TROCAR GCJ ETHICON ENDO-SURGERY, INC. B11LT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other