BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    +IO - 5MM GUARD TROCAR (KIT 2 SLV) 65MM W/GAS

    MDR report key: 1983790 · Received January 20, 2011

    Report

    Report Number
    2647580-2011-00044
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP OVARIAN CYST. ACCORDING TO THE RPTR: THE SURGEON OPENED THE 5.5MM TROCAR (4216) AND USED FOR 5MM INSTRUMENT INSERTION. AFTER USED FOR SEVERAL MINS, HE FOUND THAT WHITE SHAVINGS HAD FALLEN INTO THE PT'S ABDOMEN. THE SURGEON THEN SUCTIONED THEM OUT AND NOTICED THAT IT CAME FROM THE TROCAR'S SEAL. HE CHANGED TO USE RE-USABLE PORT TO CONTINUE THE PROCEDURE AND COMPLAINT ABOUT THE QUALITY OF ORANGE TROCAR. NO PT INJURY WAS REPORTED. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 +IO - 5MM GUARD TROCAR (KIT 2 SLV) 65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0G0663

    Patients

    Seq Age Sex Outcome Treatment
    1