BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP

    MDR report key: 3790619 · Received May 5, 2014

    Report

    Report Number
    0001811755-2014-01610
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE DEVICE WAS SCRAPPED AT THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP WAS BEING SET UP FOR A PROCEDURE WHEN THE TIP BECAME SEPARATED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP WAS BEING SET UP FOR A PROCEDURE WHEN THE TIP BECAME SEPERATED FROM THE SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268992 INTERPULSE HANDPIECE WITH COAXIAL BONE CLEANING TIP LAVAGE, JET FQH STRYKER INSTRUMENTS-KALAMAZOO 14035012

    Patients

    Seq Age Sex Outcome Treatment
    1