BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-FLEX TRIANGULAR RETRACTOR 60MM 5MM

    MDR report key: 2033314 · Received March 30, 2011

    Report

    Report Number
    1038548-2011-00004
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE RECEIVED CONFIRMED THE REPORTED ISSUE. THE CABLE FAILED ON ONE SIDE NEAR THE END OF THE RIGID TUBE. OBSERVATIONS OF THE DEVICE INCLUDE, THE RIGID TUBE WAS DEFORMED BEGINNING NEAR THE HANDLE (APPROX. 1" BELOW HANDLE) ONE (1) OF THE TWO (2) NIPPLES THAT HOLDS THE CABLE IN PLACE WAS MISSING. THE NIPPLES THAT HOLD THE CABLE IN PLACE IS PART OF A MANUFACTURING PROCESS AND DESIGNED TO WITHSTAND AT LEAST 300 LBS OF PRESSURE. THE FAILURE OF THE NIPPLE INDICATES THAT THE DEVICE WAS USED / HANDLED IN A MANNER ONE WOULD NOT EXPECT FROM NORMAL USE. ROOT CAUSE FOR THE CABLE FAILURE IS ATTRIBUTED TO A COMBINATION OF WORK HARDENING AND EXTREME OVERSTRESS. A REVIEW OF THE DHR'S FOR THE LOTS MANUFACTURED IN (B)(4) 2006 DID NOT REPORT ANY NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED FAILURE.

    Description of Event or Problem · 1

    BROKE DURING PROCEDURE, WIRE SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-FLEX TRIANGULAR RETRACTOR 60MM 5MM RETRACTOR GCJ CAREFUSION 89-6109 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention