BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE POINTER

    MDR report key: 3192476 · Received June 27, 2013

    Report

    Report Number
    0001811755-2013-01479
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HAW
    PMA / PMN Number
    K993239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POINTER IS NOT A REPAIRABLE DEVICE AND WILL THEREFORE NOT BE RETURNED TO THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, THE BLACK LED COVER WAS CONFIRMED TO BE BROKEN OFF AND THE TIP WAS CONFIRMED TO BE BENT. MECHANICAL IMPACTS DURING USE OR CERTAIN CLEANING AND STERILIZATION PRACTICES AT THE USER ACCOUNT ARE PROBABLE CAUSES OF THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED, IF ADDITIONAL INFORMATION IS OBTAINED AND REQUIRES REPORTING. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE EVALUATION AT THE GERMAN USER FACILITY BY THE MANUFACTURER TECHNICIAN, THE TIP OF THE POINTER WAS FOUND BENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER STERILIZATION PRIOR TO A CRANIOTOMY PROCEDURE AT THE USER FACILITY, THE DEVICE TRAY WAS UNWRAPPED AND THE SMALL BLACK PIECE AROUND THE LED ON THE TOP OF THE POINTER HAD BROKEN OFF IN THE DEVICE TRAY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. IT WAS REPORTED THAT A BACK-UP POINTER WAS USED TO PERFORM THE SURGICAL PROCEDURE FOLLOWING THE REPORTED EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT DURING THE DEVICE EVALUATION AT THE (B)(6) USER FACILITY BY THE MANUFACTURER TECHNICIAN, THE TIP OF THE POINTER WAS FOUND BENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER STERILIZATION PRIOR TO A CRANIOTOMY PROCEDURE AT THE USER FACILITY, THE DEVICE TRAY WAS UNWRAPPED AND THE SMALL BLACK PIECE AROUND THE LED ON THE TOP OF THE POINTER HAD BROKEN OFF IN THE DEVICE TRAY. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. IT WAS REPORTED THAT A BACK-UP POINTER WAS USED TO PERFORM THE SURGICAL PROCEDURE FOLLOWING THE REPORTED EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292872 LARGE POINTER NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1