BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 2971444 · Received June 25, 2007

    Report

    Report Number
    2955842-2007-00551
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Report Date
    June 25, 2007
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Removal / Correction Number
    2955842-2/22-07-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING CONDUCTED MECHANICAL TESTING AND FOUND THE INSTRUMENT TO THE PERFORMING PER SPECIFICATION. DURING EVAL, ENGINEERING OBSERVED THAT THE INSTRUMENT MAIN TUBE HAD A 4" SECTION WITH SCRAPING ALL AROUND THE MAIN TUBE. IT WAS DETERMINED THAT THE FAILURE MODE IS CONSISTENT WITH THE USE OF A POTENTIALLY DEFECTIVE CANNULA ACCESSORY, WHICH MAY REMOVE MATERIAL FROM THE INSTRUMENT DURING USE. THE SITE HAS RETURNED DEFECTIVE CANNULAE ACCESSORY PER REMOVAL REPORTING NUMBER 2955842-2/22/07-001-R. MFR REPORTS OF THESE DEFECTIVE CANNULAE TO FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DULL. NO ADDITIONAL INFO HAS BEEN PROVIDED. 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 GEI INTUITIVE SURGICAL, INC. 420179-04 0808061 79

    Patients

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