BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3643001 · Received February 24, 2014

    Report

    Report Number
    2955842-2014-01074
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 28, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE INSTRUMENT WAS EXAMINED AND NO PART OF THE INSTRUMENT CAME APART. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH THE LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE .050 - .148 IN LENGTH AND WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT CAME APART. NO MISSING OR FALLEN PIECES WERE REPORTED. 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
    112209 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10120920 280

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR