BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTERILIZED SURGASSIST LINEAR CUTTER

    MDR report key: 1021595 · Received March 25, 2008

    Report

    Report Number
    2090040-2008-00002
    Event Type
    Malfunction
    Date Received
    March 25, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RECEIVED BY ASCENT HEALTHCARE SOLUTIONS AS AN OPEN-BUT-UNUSED DEVICE FOR RESTERILIZATION. THE DEVICE WAS SENT IN WITH THE OEM LABELING. ASCENT UTILIZED THE OEM LABELING TO IDENTIFY THE DEVICE AS MODEL NUMBER RALC30V AND TO CREATE A NEW LABEL FOR THE DEVICE. THE DEVICE WAS THEN REPACKAGED WITH NEW PACKAGING MATERIALS, RELABELED, AND STERILIZED BY ASCENT THROUGH OUR RESTERILIZATION PROGRAM. THIS DEVICE WAS NOT REPROCESSED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO ASCENT BY THE CUSTOMER WHO INDICATED THAT THE DEVICE WAS MISLABELED AS A VASCULAR DEVICE (RALC30V) WHEN THE DEVICE IS ACTUALLY A GI DEVICE. ASCENT CONFIRMED THAT THE CORRECT MODEL NUMBER FOR THE DEVICE IS RALC30, A NON-VASCULAR DEVICE. THE DEVICE WAS NOT USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTERILIZED SURGASSIST LINEAR CUTTER GCJ ASCENT HEALTHCARE SOLUTIONS RALC30V 344805U

    Patients

    Seq Age Sex Outcome Treatment
    1