BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARITRAK TABLE CLAMP WITH VERTICAL POST

    MDR report key: 880786 · Received September 20, 2006

    Report

    Report Number
    2430952-2006-00038
    Event Type
    Malfunction
    Date Received
    September 20, 2006
    Report Date
    September 6, 2006
    Manufacturer
    KOROS USA, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTEGRA MARKETING PRODUCT MANAGER REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT: DURING THE SETUP OF THE JARITRAK RETRACTOR SYSTEM, DURING A SURGICAL PROCEDURE, THE LOCKING MECHANISM FOR THE RING FAILED. THIS NECESSITATED THE BREAK-DOWN OF THE JARITRAK, AND ANOTHER RETRACTOR WAS BROUGHT INTO THE ROOM CAUSING A DELAY IN THE SURGICAL PROCEDURE. THE REPRESENTATIVE WAS NOT IN THE ROOM AT THE TIME OF THE INCIDENT. NO PATIENT INJURY OR INCIDENT REPORT WAS FILED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARITRAK TABLE CLAMP WITH VERTICAL POST JARIT SURGICAL INSTRUMENTS FWZ KOROS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *