BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRE-OWNED UNIVERSAL DRIVER

    MDR report key: 1731992 · Received December 22, 2009

    Report

    Report Number
    1811755-2009-01015
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    May 14, 2009
    Report Date
    May 14, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K943569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED BY THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED AND A COMPONENT FAILURE WAS DETERMINED AS THE CAUSE OF THE RUN-ON CONDITION. THE COMPONENT FAILED DUE TO CORROSION, WHICH IS MOST LIKELY CAUSED BY IMPROPER CLEANING/STERILIZATION TECHNIQUES. THE COMPONENT WAS REPLACED AND THE HANDPIECE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. THERE WAS NO REPORT OF PATIENT OR USER INJURY, OR OF ANY ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRE-OWNED UNIVERSAL DRIVER DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLU ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK