BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND-FLEX CIRCULAR RETRACTOR

    MDR report key: 1122443 · Received February 28, 2008

    Report

    Report Number
    1423507-2008-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    January 17, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVAL. THE BIOMEDICAL ENGINEERING DEPT AT THE HOSP SENT SOME PHOTOGRAPHS BY E-MAIL FOR REVIEW. A REVIEW OF THE PHOTOGRAPHS NOTED THAT THE CABLE WAS BROKEN AND FRAYED AT THE POINT OF FAILURE, HOWEVER, IT COULD NOT BE DETERMINED IF A PORTION OF THE CABLE WAS MISSING. IT WAS ALSO NOTED THAT WHOLE DEVICE WAS NOT PRESENT. THE END SEGMENT WITH THE NITINOL WIRE ATTACHED WAS NOT PRESENT AND TWO SMALL SEGMENTS WERE MISSING. AFTER ENLARGING THE PHOTOGRAPHS, IT WAS OBSERVED THAT THE OUTER PORTION OF THE TUBE-RETAINING SETSCREW HAD BEEN DAMAGED. IT WAS ALSO OBSERVED THAT ON MULTIPLE SEGMENTS, THERE APPEARED TO BE SOME DEFORMATION CONSISTENT WITH DUCTILE/TENSILE BREAKAGE. A DEVICE HISTORY REVIEW WAS CONDUCTED WITH NO ISSUES NOTED FOR REPORTED LOT. BASED ON THE PHOTOGRAPHS, THE CABLE BREAKAGE AND WHAT COULD BE SEEN FROM OBSERVATIONS OF SOME OF THE SEGMENTS, THE ROOT CAUSE FOR THIS CONDITION IS INDICATIVE OF MECHANICAL OVERSTRESS (TENSILE FAILURE OF CABLE). NO ABSOLUTE CAUSE OF THE CABLE FAILURE CAN BE DETERMINED, BUT IT IS POSSIBLE FOR THE CABLE TO FAIL AT THE POINT WHERE IT EXISTS THE RIGID TUBE IF THE UNIT IS NOT PROPERLY HANDLED PER THE INSTRUCTIONS FOR USE. THE IFU REQUIRES THAT THE DEVICE BE STERILIZED IN THE STRAIGHT POSITION WITH THE STERILIZATION SLEEVE.

    Description of Event or Problem · 1

    BROKE - CABLE BROKE DURING SURGERY. ADDITIONALLY, ACCOUNT STATED THE RETRACTOR BROKE AND THE SEGMENTS FELL OFF INSIDE OF THE PT. THE PHYSICIAN CONVERTED TO AN OPEN PROCEDURE, AND COMPLETED THE CASE. X-RAY WAS TAKEN AND NO SEGMENTS WERE SEEN IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND-FLEX CIRCULAR RETRACTOR RETRACTOR GAD CARDINAL HEALTH 89-6121 8694

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention