BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3084580 · Received February 15, 2006

    Report

    Report Number
    1056128-2006-00034
    Event Type
    Malfunction
    Date Received
    February 15, 2006
    Date of Event
    December 13, 2005
    Report Date
    December 19, 2005
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS FROM OPERATING ROOM STAFF TO MANUFACTURER'S REP INDICATE THAT USER ERROR MAY HAVE CONTRIBUTED TO THIS EVENT. INVESTIGATION INTO A SIMILAR REPORT SHOWED THAT THE TIP PROTECTORS APPLIED TO THE DEVICE PRIOR TO SHIPMENT WERE SHOWN TO BE DIFFICULT TO REMOVE IN THE FIELD. END USERS WHO GRASPED THE TIP PROTECTOR WITH EXCESS FORCE MAY HAVE COMPROMISED THE ADHESIVE BOND BETWEEN OPTICAL TIP AND THE SHAFT OF THE TROCAR. NEW PROTOCOLS CALL FOR A ROOMIER TIP THAT FACILITATES EASY REMOVAL AT THE USER SITE.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC PROCEDURE, THE TIP OF AN OPTICAL TROCAR DETACHED FROM THE DEVICE IN THE SUBCUTANEOUS TISSUE OF THE PATIENT. PALPATION AND A CT SCAN WERE USED IN UNSUCCESSFUL ATTEMPTS AT RETRIEVING THE TIP. THE PATIENT HAS REPORTED NO ADVERSE REACTIONS. THE DEVICE WAS NOT RETURNED TO VANGUARD MEDICAL CONCEPTS FOR EVALUATION. NO PROPER ANALYSIS COULD BE PERFORMED TO CONFIRM THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA OPTICAL TROCAR GCJ VANGUARD MEDICAL CONCEPTS, INC. 35NLT 82594

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR