BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    400 ML SURGIVAC 1/8 PVC W/ TROCAR

    MDR report key: 2980659 · Received February 22, 2013

    Report

    Report Number
    1526350-2013-00089
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. A REVIEW OF THE MFG RECORDS WAS PERFORMED AND THERE WERE NO NON-CONFORMANCES DURING THE MFR THAT WOULD BE RELATED TO THIS COMPLAINT. ALL TESTING REQUIREMENTS WERE MET. THE DEVICE WAS LEAK AND VACUUM TESTED PER PROCEDURE AND WAS NOTED TO FAIL THE TESTING. OBSERVATION OF THE RETURNED DEVICE IDENTIFIED WITNESS MARKS ON THE SIDE OF THE BELLOW TOWARD THE BOTTOM AT THE LOCATION OF THE LEAK. THE MARKS ARE IN A STRAIGHT LINE AND APPEAR TO HAVE COME FROM THE OUTSIDE OF THE BELLOW TO THE INSIDE. THE UNIT WAS FILLED WITH TAP WATER AND PRESSURE WAS APPLIED, A SMALL AMOUNT OF WATER WAS FOUND TO BE EXITING OUT OF THE BELLOW IN THE AREA OF THE WITNESS MARKS. THE CAUSE OF THE WITNESS MARKS COULD NOT BE DETERMINED. THE COMPLAINT WAS CONFIRMED. HOWEVER, THE ROOT CAUSE OF THE LEAK COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER 400 ML SURGIVAC WAS NOT AVAILABLE FOR USE DUE TO AN AIR LEAK IN "HOLD" POSITION OF THE DEVICE. THERE WAS NO REPORT OF HARM OR DELAY AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77576 400 ML SURGIVAC 1/8 PVC W/ TROCAR 400 ML SURGIVAC 1/8 PVC W/ TROCAR GCY ZIMMER SURGICAL NA 61639961

    Patients

    Seq Age Sex Outcome Treatment
    1