BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNKTKALIBRIERUNGSGERÄT (PCD)

    MDR report key: 3115995 · Received May 16, 2013

    Report

    Report Number
    0001811755-2013-01117
    Event Type
    Malfunction
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, THE DEVICE WAS FOUND TO HAVE SPORADIC ELECTRONICS, CORRODED BATTERY CONTACTS AND DAMAGED PARYLENE COATING ON THE BOARD OF THE DEVICE. THE PCD IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POINT CALIBRATION DEVICE (PCD) CAUSED A ONE HOUR DELAY BECAUSE THE LEDS WERE NOT WORKING DURING A FESS (FUNCTIONAL ENDOSCOPY SINUS SURGERY) PROCEDURE. AN ALTERNATE DEVICE WHICH WAS NOT READILY AVAILABLE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT BUT ADDITIONAL ANESTHESIA WAS REQUIRED DURING THE WAIT FOR THE ALTERNATE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POINT CALIBRATION DEVICE (PCD) CAUSED A ONE HOUR DELAY BECAUSE THE LEDS WERE NOT WORKING DURING A FESS (FUNCTIONAL ENDOSCOPY SINUS SURGERY) PROCEDURE. AN ALTERNATE DEVICE WHICH WAS NOT READILY AVAILABLE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT BUT ADDITIONAL ANESTHESIA WAS REQUIRED DURING THE WAIT FOR THE ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216730 PUNKTKALIBRIERUNGSGERÄT (PCD) STEREOTAXIC HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1