BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRODEBRIDER 1898200T IGS M4

    MDR report key: 2972450 · Received February 21, 2013

    Report

    Report Number
    1045254-2013-00135
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 17, 2013
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K041413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. FOLLOW-UP WITH THE INITIAL REPORTER FOUND THAT THE EVENT DATE IS UNKNOWN AS THE DEVICE WAS GIVEN TO HER SOME TIME AGO WITH A REQUEST FOR REPAIR. SHE SAID THAT THERE WAS NO IMPACT OR INJURY OF A USER OR PATIENT INVOLVEMENT. SHE ALSO STATED THAT IF THE INCIDENT WAS SEVERE ENOUGH AN INCIDENT REPORT WOULD HAVE BEEN FILED WITH RISK MANAGEMENT AND SHE WOULD HAVE BEEN AWARE OF THAT. (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR. THE SERVICE TECHNICIAN IDENTIFIED THE WHEEL WAS LOCKED DUE TO DRIED SALINE. THE REPORTED "HEATING UP" COULD NOT BE DUPLICATED OR CONFIRMED AS THE HANDPIECE WAS NOT WORKING WHEN IT ARRIVED FOR REPAIR. THE MOTOR BEARINGS WERE FOUND TO BE CORRODED WHICH PREVENTED THE SHAFT TO ROTATE AND LIKELY CONTRIBUTED TO THE REPORTED NOISE ISSUE. THE DEVICE WAS REPAIRED AND TESTED TO SPECIFICATIONS AND HAS BEEN RETURNED TO THE CUSTOMER. A REVIEW OF THE DEVICE MAINTENANCE HISTORY FOUND THE DEVICE WAS RETURNED IN 2009 AND THE DEVICE WAS REPAIRED FOR "MOTOR FROZEN"; NO FURTHER MAINTENANCE HISTORY WAS NOTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER'S SERVICE AND REPAIR DEPARTMENT THAT THE MICRODEBRIDER "HANDLE IS NOT WORKING; HEATING UP; SOUNDS FUNNY." THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF USER IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76768 MICRODEBRIDER 1898200T IGS M4 DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE 1898200T 47105200

    Patients

    Seq Age Sex Outcome Treatment
    1