BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2193548 · Received August 5, 2011

    Report

    Report Number
    2090040-2011-00013
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NQG
    PMA / PMN Number
    K070036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) WITHOUT ANY PACKAGING OR LABELING SO DEVICE INFORMATION SUCH AS LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE ARE ALL UNKNOWN. THE DEVICE WAS SUBJECTED TO IN-LINE INSPECTION AND WAS REJECTED DUE TO THE BALL BEARING BETWEEN THE CLAW LUMEN BEING CRACKED. THIS BALL IS USED FOR POSITIONING PURPOSES ONLY AND HAS NO BEARING ON THE SUCTION CAPABILITIES. THE BEARING MOST LIKELY CRACKED DURING CLINICAL USE AND/OR TRANSIT BACK TO SSS. THE RETURNED DEVICE WAS TESTED TO CONFIRM THE DEVICE WAS ABLE TO MAINTAIN SUCTION. THE DEVICE PASSED ALL FUNCTION TESTING. BASED ON THE EVIDENCE THAT THE REPORTED FAILURE MODE COULD NOT BE DUPLICATED, THE MOST PROBABLE ROOT CAUSE IS DUE TO USER ERROR. ALL SSS'S REPROCESSED CARDIAC STABILIZATION DEVICES ARE 100% FUNCTION TESTED AND INSPECTED BEFORE LEAVING SSS. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SUCTION AT THE END OF THE ARM OF THE CARDIAC STABILIZATION DEVICE WAS NOT HOLDING PROPERLY AND CAUSED THE DEVICE TO DRAG WHICH CAUSED ABRASIONS TO THE HEART TISSUE. THE USER FACILITY STATED THERE WAS NO TREATMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NQG NQG STRYKER SUSTAINABILITY SOLUTIONS 29403-K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other