BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPACEMAKER BLUNT TIP TROCAR

    MDR report key: 561106 · Received January 14, 2004

    Report

    Report Number
    561106
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 17, 2003
    Report Date
    January 9, 2004
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GDH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN INSERTING A BLUNT TROCAR FOR LAPAROSCOPIC CHOLECYSTECTOMY, A SMALL PIECE OF METAL WAS SEEN ON THE PATIENT'S ABDOMEN. THE TROCAR WAS PLACED IN THE PATIENT AND IT DID NOT LOCK IN PLACE. THE DEFECTIVE TROCAR AND THE PIECE OF METAL WERE REMOVED FROM THE FIELD. THE SURGEON DECLINED AN X-RAY. NO APPARENT INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACEMAKER BLUNT TIP TROCAR BLUNT TIP TROCAR-10MM GDH UNITED STATES SURGICAL CORPORATION * P3E372

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR NO OTHER THERAPIES