BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND-FLEX TRIANGULAR RETRACTOR

    MDR report key: 1031995 · Received April 21, 2008

    Report

    Report Number
    1423507-2008-00036
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 21, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE DEVICE REC'D FOR EVALUATION CONFIRMED THAT THE CABLE BROKE. IT NOTED THAT NOT ALL OF THE PIECES WERE ACCOUNTED FOR. OBSERVATIONS INCLUDE, TWO SEGMENTS WERE MISSING, CABLE WAS BROKEN AND FRAYED AT THE ENDS, A SECTION OF THE CABLE HAD BEEN COMPLETELY REMOVED FROM THE DEVICE, END ARRANGEMENT WITH NITINOL WIRE WITH MOST OF THE SEGMENTS WAS SEPARATED FROM THE DEVICE. ROOT CAUSE OF FAILURE IS CONSISTENT WITH MECHANICAL OVERSTRESS. THE CONDITION OF THE UNIT FURTHER SUPPORTS THIS CONCLUSION. ONE SIDE OF THE CABLE BROKE WHERE IT EXITS THE RIGID SHAFT. THE OTHER SIDE OF THE CABLE LOOP IS STARTING TO FRAY AT THE SAME LOCATION. NO ABSOLUTE CAUSE OF THE CABLE FAILURE CAN BE DETERMINED. IT IS POSSIBLE FOR THE CABLE TO FAIL AT THE POINT WHERE IT EXISTS THE RIGHT TUBE IF THE UNIT IS NOT STERILIZED IN THE STRAIGHT POSITON WITH THE STERILIZATION SLEEVE PER OUR IFU. SOMETIMES USERS SEVERELY BEND THE UNIT TO FIT IT IN A STERILIZATION TRAY. THIS WILL KINK AND FRAY THE CABLE AT THIS LOCATION. THE DEVICE HISTORY WAS REVIEWED AND NO ISSUES WERE FOUND WITH THE REPORTED LOT.

    Description of Event or Problem · 1

    CABLE BROKE IN PT. DR ABLE TO RETRIEVE IT. ADDITIONALLY, ACCOUNT STATED THE PHYSICIAN WAS DOING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHEN THE RETRACTOR BROKE AND THE SEGMENTS FELL INTO THE PT. THE PHYSICIAN WENT BACK IN WITH A GRASPER AND RETRIEVED THE SEGMENTS. AN X-RAY WAS ORDERED AND CONFIRMED NO SEGMENTS WERE LEFT INSIDE OF THE PT. THE CASE WAS PROLONGED; THEREFORE, THE PT WAS GIVEN EXTRA ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND-FLEX TRIANGULAR RETRACTOR RETRACTOR GAD CARDINAL HEALTH 89-6212 782916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention