BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP

    MDR report key: 3760742 · Received April 21, 2014

    Report

    Report Number
    0001811755-2014-01393
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE THE PRODUCT IS WITHIN SPECIFICATION, OUR INVESTIGATION HAS CONCLUDED THAT THIS EVENT WAS A RESULT OF A VARIATION IN THE INNER DIAMETER FOR COMPONENTS MANUFACTURED BETWEEN JANUARY 16, 2014 AND APRIL 4, 2014. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP WAS BEING USED IN A HIP PROCEDURE WHEN IT FELL OFF AND INTO THE SURGICAL SITE. THE TIP WAS REMOVED BY HAND, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP WAS BEING USED IN A HIP PROCEDURE WHEN IT FELL OFF AND INTO THE SURGICAL SITE. THE TIP WAS REMOVED BY HAND, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239979 INTERPULSE HANDPIECE WITH COAXIAL FAN SPRAY TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 14049012

    Patients

    Seq Age Sex Outcome Treatment
    1