BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5-POLE SPRING ARM AC 2000 15-21KG

    MDR report key: 1845204 · Received September 14, 2010

    Report

    Report Number
    2031963-2010-00117
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT, THUS NO PATIENT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. ACTUAL DEVICE WAS EVALUATED IN THE FIELD ON (B)(6) 2010. EVALUATION SUMMARY: AFTER EVALUATION BY THE FIELD SERVICE TECHNICIAN, IT WAS FOUND THAT THE PLASTIC COVERING THE ELBOW OF LIGHT SPRING ARM 3 WAS SLIGHTLY POPPED OPEN AND THE FLEX STRIP AT THE TOP PART WAS MISSING. THE TECHNICIAN CONCLUDED THAT THE FLEX STRIP FELL OFF BECAUSE THE PLASTIC MOLDING HOLDING IT POPPED OPEN DUE TO THE SPRING ARM BEING MOVED AT A CERTAIN ANGLE. THE ROOT CAUSE OF THIS MALFUNCTION IS LIKELY USER MISUSE. IN THIS CASE, THE FLEX STRIP WAS REPLACED AT THE ACCOUNT. THIS TYPE OF MALFUNCTION POSES A POTENTIAL SERIOUS RISK TO A USER IF THE FLEX STRIP WERE TO FALL INTO THE STERILE FIELD. HOWEVER, THIS SPECIFIC MALFUNCTION DID NOT NEGATIVELY IMPACT THE PATIENT, AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT OPERATING ROOM (B)(6) HAD A FLEX STRIP FROM THE SPRING ARM FALL OUT ONTO A STERILE TRAY DURING THE MIDDLE OF A PROCEDURE. IT WAS REPORTED THE PATIENT WAS A (B)(6) FEMALE, BUT THERE WAS NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5-POLE SPRING ARM AC 2000 15-21KG FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR