BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1X HUNT TROCAR 5MM PYRAMIDAL TIP

    MDR report key: 384572 · Received March 21, 2002

    Report

    Report Number
    1221923-2002-00002
    Event Type
    Malfunction
    Date Received
    March 21, 2002
    Date of Event
    February 27, 2002
    Report Date
    March 6, 2002
    Manufacturer
    APPLE MEDICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    1MM - 1 1/2MM SECTION OF TROCAR SLEEVE MISSING FROM END, NOTICED AFTER TROCAR USED. PRODUCT SENT TO MANUFACTURER. UNABLE TO DETERMINE IF MISSING SECTION EMBEDDED IN PATIENT. NO ADVERSE OUTCOME NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1X HUNT TROCAR 5MM PYRAMIDAL TIP TROCAR SLEEVE GCJ APPLE MEDICAL CORPORATION * D133705

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR