BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLOAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1810367 · Received August 20, 2010

    Report

    Report Number
    2955842-2010-00378
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, THE TIP OF ONE SCISSOR BLADE IS BROKEN OFF. THE BROKEN BLADE IS APPROXIMATELY 0.160 X 0.420. THE FRACTURE PLANE OF THE BROKEN BLADE IS NOT STRAIGHT AND THE BLADE HAS A CHIP ON THE EDGE BELOW THE MIDPOINT. THE INTACT BLADE DOES NOT EXHIBIT ANY OBVIOUS CRACKING. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS A REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED 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 MONOPLOAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-09 M10091214 662

    Patients

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