BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

    MDR report key: 3130907 · Received May 24, 2013

    Report

    Report Number
    2955842-2013-01845
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION CONFIRMED THAT THE INSTRUMENT HAD FRAYED WIRES. THE INSTRUMENT WAS FOUND TO HAVE ONE GRIP CABLE BROKEN AT THE DISTAL IDLERS. THE BROKEN CABLE SEGMENT WAS FOUND TO BE .3330 IN LENGTH AND WAS STICKING OUT AT THE INSTRUMENT'S WRIST. THE OTHER CABLES OF THE INSTRUMENT'S WRIST DID NOT EXHIBIT ANY DAMAGE. ENGINEERING EVALUATION ALSO OBSERVED DAMAGE ALONG THE EDGES OF THE IDLER PULLEYS. EACH IDLER PULLEY WAS FOUND TO HAVE AN INDENTATION ON THE EDGE. ENGINEERING EVALUATION CONCLUDED THAT THE DAMAGES ON THE PULLEYS WERE LIKELY DUE TO MISHANDLING. THE IDLER PULLEYS WERE ABLE TO SPIN FREELY. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. INTUITIVE SURGICAL HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT HAD FRAYED WIRES AND AN UNSPECIFIED FRAGMENT BROKE OFF AND FELL INTO THE PATIENT. THE SURGICAL STAFF INDICATED THAT THE FRAGMENT WAS RETRIEVED AND THE SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232129 MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420309-01 M10130123 736

    Patients

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