BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGASUTURECUT NEEDLEDRIVER INSTRUMENT

    MDR report key: 3000115 · Received March 8, 2013

    Report

    Report Number
    2955842-2013-00778
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ON GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS AND THERE WAS DAMAGE ON IDLER PULLEYS. THERE WERE MANY DENTS ALONG THE EDGES OF THE IDLER PULLEY, WHICH LIKELY CAUSED THE CABLE TO BREAK. ENGINEERING CONCLUDED THAT THE DENTS ON THE IDLER PULLEY WERE LIKELY CAUSED BY MISHANDLING. THE BROKEN CABLE SEGMENT STUCK OUT AT THE WRIST APPROXIMATELY .5155". NO OTHER DAMAGE WAS FOUND. THE INSTRUMENT 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. THE CUSTOMER REPORTED COMPLAINT DOES NOT 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE CABLE ON THE MEGASUTURECUT NEEDLEDRIVER INSTRUMENT WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98780 MEGASUTURECUT NEEDLEDRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT, NAY NAY INTUITIVE SURGICAL, INC. 420309-01 M10121112 732

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| DA VINCI SI SURG. SYS.| INSTRUMENTS