BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 1070072 · Received July 3, 2008

    Report

    Report Number
    2955842-2008-01112
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONFIRMED THE TUBE EXTENSION IS BROKEN AND MISSING A .250 INCH BY .285 INCH PIECE AT THE PROXIMAL CLEVIS INTERFACE. THE CLEVIS IS DISLODGED FROM THE TUBE EXTENSION. ENGINEERING CONCLUDED THE TUBE EXTENSION WAS MOST LIKELY BROKEN DUE TO EXCESSIVE SIDE LOADING OR OTHER MISHANDLING OR MISUSE. PER THE CASE NOTES, THERE ARE NO INDICATIONS FROM THE SITE THAT THE MISSING INSTRUMENT COMPONENTS FELL INSIDE OF A PATIENT DURING A SURGICAL PROCEDURE. ENGINEERING ALSO OBSERVED THE DISTAL END OF THE MAIN TUBE HAS A 3.5 INCH LONG SECTION WITH MATERIAL REMOVED ALL AROUND THE TUBE. THE DAMAGED SECTION IS PARALLEL TO THE TUBE AXIS AND 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 INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP MONOPOLAR CURVED SCISSORS INSTRUMENT IS BROKEN, AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFO PROVIDED. NO PATIENT 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 GEI INTUITIVE SURGICAL, INC. 420179-08 0801211 792

    Patients

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