BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARITRAK TABLE CLAMP WITH VERTICAL POST

    MDR report key: 880805 · Received September 20, 2006

    Report

    Report Number
    2430952-2006-00037
    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
    MD, 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: THE TABLE CLAMP DID NOT SECURE TO THE RAIL OF THE OPERATING ROOM BED. AS A RESULT THE RETRACTOR SYSTEM WAS NOT STEADY AFTER SETUP, DURING THE SURGICAL PROCEDURE. TWO IN-SERVICES WERE PERFORMED ON HOW TO ATTACH THE TABLE CLAMP TO THE BED. THE CUSTOMER REQUESTED A REPLACEMENT.

    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 *