BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3230520 · Received July 16, 2013

    Report

    Report Number
    2955842-2013-02574
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING DID NOT CONFIRM A WIRE SNAPPED COMPLAINT; HOWEVER, THE INSTRUMENT WAS RETURNED WITH A FRAYED PITCH CABLE STICKING OUT AT THE DISTAL CLEVIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI URETERECTOMY PROCEDURE, THE WIRE SNAPPED AT THE TIP OF THE LARGE NEEDLE DRIVER INSTRUMENT. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328210 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10120502 455

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES