BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARITRAK TABLE CLAMP WITH VERTICAL POST

    MDR report key: 808049 · Received October 6, 2006

    Report

    Report Number
    2430952-2006-00040
    Event Type
    Malfunction
    Date Received
    October 6, 2006
    Report Date
    October 6, 2006
    Manufacturer
    KOROS USA, INC.
    Product Code
    HXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR.

    Description of Event or Problem · 1

    THE JARIT SALES REP REPORTED ON BEHALF OF THE USER FACILITY THE FOLLOWING INCIDENT. THE TABLE CLAMP IS NOT SECURING TO THE RAIL ON THE OR BED. AS A RESULT, THE REST OF THE RETRACTOR SYSTEM IS NOT STEADY/STABLE AFTER SET UP AND DURING SURGICAL PROCEDURES. AN IN-SERVICE WAS PREFORMED ON HOW TO ATTACH THE TABLE CLAMP ON TO THE RAIL. THE USER FACILITY HAS REQUESTED A REPLACEMENT, BECAUSE THE ISSUE HAS PERSISTED. NO PT INJURY HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *