BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS SMALL ACCESS RETRACTOR

    MDR report key: 1070644 · Received July 1, 2008

    Report

    Report Number
    3005075853-2008-00231
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY. THE ANALYSIS RESULTS FOUND THAT THE DEVICE HAD A TWO-INCH VERTICAL TEAR BEGINNING AT THE UPPER RETRACTOR RING. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURN CONDITION OF THE DEVICE. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE FOUND DAMAGE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THAT THE DEVICE WAS DAMAGED IN THE PACKING. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS SMALL ACCESS RETRACTOR GCJ ETHICON ENDO-SURGERY, LLC NA D4JM18

    Patients

    Seq Age Sex Outcome Treatment
    1