BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT

    MDR report key: 880760 · Received September 20, 2006

    Report

    Report Number
    2430952-2006-00036
    Event Type
    Malfunction
    Date Received
    September 20, 2006
    Report Date
    September 6, 2006
    Manufacturer
    KOROS USA, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INTEGRA PRODUCT MANAGER REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT. DURING THE SETUP OF THE JARITRAK RETRACTOR SYSTEM, THE SURGEON TIGHTENED DOWN ON THE FLEX BALL AND THE TIGHTENING MECHANISM BROKE OFF IN HIS HAND. THE SPRING ON THE OPPOSITE SIDE POPPED OUT ON TO THE FLOOR. THE JARITRAK WAS DISASSEMBLED, AND ANOTHER RETRACTOR WAS BROUGHT INTO THE ROOM AND USED FOR THE CASE. THE INCIDENT CAUSED A DELAY DURING THE PROCEDURE. THE REPRESENTATIVE WAS NOT IN THE ROOM AT THE TIME OF THE INCIDENT. NO PATIENT INJURY OR INCIDENT REPORT HAD BEEN FILED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARITRAK HORIZONTAL FLEX BAR, UNIVERSAL JOINT JARIT SURGICAL INSTRUMENTS GAD KOROS USA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *