BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEVE 5MM DIAM.,WITH THREAD

    MDR report key: 2103057 · Received May 25, 2011

    Report

    Report Number
    9680837-2011-00005
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 2, 2011
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTS
    Product Code
    HET
    PMA / PMN Number
    K993653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS USED FOR TREATMENT AND NOT FOR DIAGNOSIS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT: DURING A LAPAROSCOPIC PROCEDURE A TROCAR SLEEVE BROKE ON THE OUTSIDE OF THE PATIENT'S ABDOMEN. THE BREAKAGE IS LOCATED IN THE MIDDLE OF THE THREADED SLEEVE. THE HOSPITAL CONFIRMED THERE WAS NO PATIENT CONSEQUENCE. RELEVANT EVENTS AND INFORMATION OBTAINED FOR THE REPORTED CASE: THE TROCAR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION FOUND SEVERAL SCRATCHES ALONG THE THREAD OF THE TROCAR. THE SCRATCHES ARE CLEARLY VISIBLE AND SHOULD HAVE BEEN NOTED PRIOR TO USE. DEVICE INSPECTION PRIOR TO USE IS RECOMMENDED BY THE INSTRUCTION FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEVE 5MM DIAM.,WITH THREAD LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET MEDTRONIC XOMED INSTRUMENTS CEV145-6 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR