BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 3983109 · Received August 6, 2014

    Report

    Report Number
    0008043928-2014-00004
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS DOCUMENTED AFTER THE DEVICE WAS RECEIVED AT THE MANUFACTURING FACILITY FOR SERVICE EVALUATION. DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE DEVICE DISPLAYING A FREQUENCY ANNUNCIATOR CAUSING A DELAY IN SURGERY WAS NOT DUPLICATED. THERE WERE NO OBSERVED FAILURES THAT COULD LEAD TO THE REPORTED EVENT. HOWEVER, THE TIP BEING INSTALLED INCORRECTLY CAN CAUSE THE FREQUENCY OF THE DEVICE TO BE OFF. BASED ON THE EVENT DESCRIPTION THE TIP WAS FOUND TO BE LOOSE, WHICH CAN CAUSE A FREQUENCY ANNUNCIATOR PER THE INSTRUCTIONS FOR USE. THE DEVICE WAS SERVICED FOR PREVENTATIVE MAINTENANCE, AND RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE COURSE OF A BRAIN TUMOR REMOVAL PROCEDURE, THE SONOPET FREQUENCY ALARM WAS ACTIVATED, PREVENTING THE UNIT FROM WORKING. AFTER TROUBLESHOOTING ATTEMPTS, THE UNIT WAS UNABLE TO BE RESET; THEREFORE, AN ALTERNATIVE METHOD WAS USED CAUSING A TOTAL DELAY TO THE PROCEDURE OF 30-40 MINUTES. NO MEDICAL INTERVENTION WAS REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ATTEMPTS ARE STILL BEING MADE TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE COURSE OF A BRAIN TUMOR REMOVAL PROCEDURE, THE SONOPET FREQUENCY ALARM WAS ACTIVATED, PREVENTING THE UNIT FROM WORKING. AFTER TROUBLESHOOTING ATTEMPTS, THE UNIT WAS UNABLE TO BE RESET; THEREFORE, AN ALTERNATIVE METHOD WAS USED CAUSING A TOTAL DELAY TO THE PROCEDURE OF 30-40 MINUTES. NO MEDICAL INTERVENTION WAS REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ATTEMPTS ARE STILL BEING MADE TO OBTAIN FURTHER INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461043 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1 5450852000 SONOPET CONSOLE S/N (B)(4)| 5450800307 SONOPET TIP LOT #UNK