BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1232774 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01384
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE TUBE EXTENSION TO BE DISLODGED FROM THE MAIN TUBE. THE ENTIRE TUBE EXTENSION WALL IS BROKEN AT THE BASE OF THE ORANGE-COLORED TUBE. AS A RESULT, THE TUBE EXTENSION CAN BE ROTATED 360 DEGREES. NO PIECES ARE MISSING. ENGINEERING CONCLUDED THAT DAMAGE MAY BE DUE TO EXCESSIVE SIDE LOADING. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE TO HAVE A 6" LONG SECTION WITH MATERIAL REMOVED AROUND THE OUTER DIAMETER OF THE TUBE. THE DAMAGED AREA HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER WASHING THE MONOPOLAR CURVED SCISSORS INSTRUMENT, A BEND AT THE ASSEMBLY POINT WAS OBSERVED. THE CAUSE WAS UNK BUT WAS NOT NOTICED DURING OR POST PROCEDURE. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CURVED SCISSORS INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420179-08 0510071 852

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURGICAL SYSTEM| ACCESSORIES| ELECTROSURGICAL UNIT