BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTIVA

    MDR report key: 2854907 · Received December 3, 2012

    Report

    Report Number
    3007566237-2012-02896
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    KNS
    PMA / PMN Number
    K052413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (HAND PIECE). (B)(4): ANALYSIS OF THE HAND PIECE, MODEL #8929, SERIAL #(B)(4), LOT # 119761, FOUND THAT THE LEFT NEEDLE THERMOCOUPLE WAS OPEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEFECTIVE HAND PIECE ERROR CODE 14 WAS RECEIVED. TROUBLESHOOTING WAS ATTEMPTED 3 TIMES WITHOUT SUCCESS. IT WAS STATED THAT THE ERROR WOULD NOT CLEAR. IT WAS NOTED THAT THE PATIENT HAD TO RESCHEDULE THE PROCEDURE DUE TO THE LACK OF A SECOND HAND PIECE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN ERROR MESSAGE CAME UP DEFECTIVE HAND PIECE AND THAT THE DEVICE WAS DISASSEMBLED AND THE PROCEDURE WAS RESTARTED TWICE WITHOUT RESOLUTION. IT WAS NOTED THAT THE PROBLEM OCCURRED PRIOR TO THE START OF THE PROCEDURE. THERE WERE NO PATIENT INJURIES AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTIVA UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS MEDTRONIC NEUROMODULATION 8929 119761

    Patients

    Seq Age Sex Outcome Treatment
    1 Other