BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3842315 · Received June 1, 2014

    Report

    Report Number
    2955842-2014-03348
    Event Type
    Malfunction
    Date Received
    June 1, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 13, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT THE INSTRUMENT WAS RECEIVED WITH ZERO LIVES REMAINING. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT'S GRIP TIPS EXHIBITED MECHANICAL INDENTATIONS/BURRS. ONE GRIP HAD INDENTATIONS AT THE MID-POINT. EVIDENCE NOT CONCLUSIVE, BUT MECHANICAL INDENTATIONS/BURRS DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND. THE ENDOWRIST® INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S MAIN TUBE FOUND DURING FAILURE ANALYSIS INVESTIGATION COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, THE SURGICAL STAFF NOTED THAT THE LARGE NEEDLE DRIVER INSTRUMENT USED IN NINE PROCEDURES, BUT THE LAST PROCEDURE INSTRUMENT HAS ZERO CREDITS. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320661 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-06 M10130613 866

    Patients

    Seq Age Sex Outcome Treatment
    1