BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND-FLEX TRIANGULAR RETRACTOR

    MDR report key: 1475104 · Received July 2, 2009

    Report

    Report Number
    1423507-2009-00080
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Date of Event
    June 11, 2009
    Report Date
    July 2, 2009
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION AND NOTED THAT ALL OF THE COMPONENTS WERE NOT PRESENT. THERE WERE FIVE SEGMENTS MISSING. THE CABLE WAS FRAYED AND BROKEN AT THE POINT OF FAILURE, A SECTION OF THE CABLE HAD BEEN COMPLETELY REMOVED FROM DEVICE, AND THE END ARRANGEMENT WITH NITINOL WIRE WAS SEPARATED FROM THE DEVICE. IT IS VIRTUALLY IMPOSSIBLE FOR THE SEGMENTS TO BECOME SEPARATED UNLESS BOTH SIDES OF THE CABLE ARE BROKEN. THE DEVICE WAS MANUFACTURED IN OCT 2003. A DHR REVIEW FOR THIS LOT DID NOT INDICATE ANYTHING THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. ROOT CAUSE FOR THE CABLE FAILURE CAN BE ATTRIBUTED TO MECHANICAL STRESS. ALTHOUGH AN ABSOLUTE CAUSE FOR CABLE FAILURE CANNOT BE DETERMINED, THIS TYPE OF FAILURE CAN BE A RESULT OF REPEATED CLEANING WITHOUT THE USE OF THE PROTECTIVE/STERILIZATION SLEEVE. AS STATED IN THE DIRECTIONS FOR USE THAT IS INCLUDED IN THE PACKAGING OF THE DEVICE "IMPORTANT NOTICE: DIAMOND-FLEX RETRACTORS MUST ONLY BE STERILIZED IN THE FULLY RELAXED POSITION. BEFORE STERILIZATION THE 'PROTECTIVE/STERILIZING SLEEVE' MUST BE LOCATED ON THE PROTECTIVE SEGMENTED PORTION OF THE INSTRUMENT. FAILURE TO FOLLOW THESE INSTRUCTIONS MAY SIGNIFICANTLY IMPAIR THE LIFE OF THE RETRACTOR. THE DFU ALSO RECOMMENDS UNDER CARE AND MAINTENANCE TO "INSPECT INSTRUMENTS BEFORE EACH USE FOR BROKEN, CRACKED, TARNISHED SURFACES, AND CHIPPED OR WORN PARTS. IF ANY OF THESE APPEAR, DO NOT USE THE INSTRUMENT."

    Description of Event or Problem · 1

    BROKE OFF IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND-FLEX TRIANGULAR RETRACTOR RETRACTOR GAD CARDINAL HEALTH 89-6112 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK