BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 1880165 · Received October 22, 2010

    Report

    Report Number
    2955842-2010-00454
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K012833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED AN ARC TRACK AND MELTED MATERIALS AT THE GRIP BASE ON THE YAW PULLEYS, INDICATING THAT AN ARCING EVENT OCCURRED. BOTH CONDUCTOR WIRES REMAINED INSIDE THE YAW PULLEY AND THE GRIP CABLES WERE FRAYED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE THE PLASTIC PORTION NEAR THE TIP OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS BURNT WHEN THE BIPOLAR ENERGY WAS FIRST ACTIVATED. THE INSTRUMENT WAS REMOVED AND REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-06 M10100205 507

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, ACCESSORIES & ESU