BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND-FLEX TRIANGULAR RETRACTOR

    MDR report key: 1842210 · Received August 26, 2010

    Report

    Report Number
    1038548-2010-00014
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 20, 2010
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE REPORT, AN INVESTIGATION WAS INITIATED. THE REPORTED DEVICE WAS NOT AVAILABLE FOR EVALUATION. BY THE DATE CODE "C03" THE LOT NUMBER WAS IDENTIFIED AS 775104. THE DEVICE WAS MANUFACTURED IN (B)(4) 2003. A REVIEW OF THE DHR DID NOT IDENTIFY ANY CONCERNS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. SINCE THE SAMPLE IS NOT AVAILABLE, A COMPLETE ANALYSIS OF IT AND THE DETERMINATION OF A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. WHEN THE DEVICE BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE MADE. CONSIDERING THE CONCERN CANNOT BE FULLY INVESTIGATED AND NOT ENOUGH INFORMATION HAS BEEN PROVIDED, A CORRECTIVE AND PREVENTIVE ACTION HAS NOT BEEN INITIATED. COMMUNICATION WITH THE CUSTOMER CONTINUES. A CORRECTIVE AND PREVENTIVE ACTION WILL BE INITIATED IF THE SAMPLE BECOMES AVAILABLE OR IF ENOUGH INFORMATION IS COLLECTED FOR THE DETERMINATION OF A CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE RETRACTOR CABLE SNAPPED AS THE SURGEON WAS TIGHTENING IT. SUBSEQUENTLY, ALL THE LINKS BECAME DETACHED FROM THE MAIN BODY AND LOOSE IN THE PATIENT. THEATRE STAFF MANAGED TO REMOVE ALL LINKS FROM THE ABDOMINAL CAVITY BUT A RISK WAS IDENTIFIED TO THE PATIENT AS PATIENT DEBRIS WAS FOUND IN THE MECHANISM OF THE INSTRUMENT (WHICH WAS NOTICED AS A RESULT OF THE FAULT). THEREFORE, THE HOSPITAL HAVE REPORTED THIS INCIDENT TO THE (B)(4), WITH THE INSTRUMENT CURRENTLY BEING HELD BY RISK MANAGEMENT AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND-FLEX TRIANGULAR RETRACTOR RETRACTOR GCJ CAREFUSION 89-6109 775104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention