BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTION

    MDR report key: 2888874 · Received December 28, 2012

    Report

    Report Number
    1045254-2012-00762
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    November 30, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K963246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. IT WAS CONFIRMED THAT THE DEVICE WAS OUT OF SPECIFICATION AND WOULD NOT TURN OFF. THE CABLE CONNECTOR PIN WAS REPLACED. THE UNIT WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THIS PRODUCT WAS BEING USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE AND PUMP WILL NOT TURN OFF. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCH 1895420 XPS MULTIFUNCTION DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE 1895420 55456000

    Patients

    Seq Age Sex Outcome Treatment
    1