BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 1190627 · Received October 3, 2008

    Report

    Report Number
    1056128-2008-00064
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    December 13, 2005
    Report Date
    October 3, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GCJ
    Removal / Correction Number
    Z-1212-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTS FROM OR STAFF TO MFR'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. THIS REPORT WAS ORIGINALLY SUBMITTED ON 12/19/2005 WITH AN INCORRECT MFR REPORT NUMBER. THIS REPORT IS BEING RE-SENT ON 10/02/2008 WITH A NEW MANUFACTURER REPORT NUMBER : 1056128-2008-00064.

    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 PT HAS REPORTED NO ADVERSE REACTIONS. THE DEVICE WAS NOT RETURNED TO ASCENT HEALTHCARE SOLUTIONS 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 ASCENT HEALTHCARE SOLUTIONS 35NLT 82594

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR