BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1861380 · Received October 8, 2010

    Report

    Report Number
    2955842-2010-00427
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    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 WITH THE DETACHED BLADE AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE BLADE FRACTURED AT THE CROSS SECTION OF THE GRIP CABLE CRIMP. THE CABLE CRIMP HAS SLIPPED OUT FROM CRIMP POCKET AND THE FRACTURED PLANE OF THE BLADE IS NEARLY STRAIGHT. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, A PART OF A BLADE FROM THE MONOPOLAR CURVED SCISSORS INSTRUMENT BROKE AND FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-09 M10100121 371

    Patients

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