BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3103618 · Received May 9, 2013

    Report

    Report Number
    2955842-2013-01590
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT. ENGINEERING PLACED THE INSTRUMENT ON AN IN-HOUSE SYSTEM WITH THE TIP COVER, AND NO SMOKE AND BUBBLING WAS OBSERVED. THE TIP COVER WAS RETURNED WITH THE INSTRUMENT AND NO FITTING ISSUE WAS FOUND. ENGINEERING ALSO FOUND PAD PRINTING REMOVED AT MULTIPLE LOCATIONS ON THE TUBE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT SMOKE AND BUBBLING WAS NOTED UNDER THE TIP COVER AT THE PROXIMAL END. THE TIP COVER WAS REMOVED AND REPLACED AND THE PROCEDURE WAS CONTINUED WITHOUT FURTHER OCCURRENCE. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204520 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 M10130211 317

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES