BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE NEEDLE DRIVER INSTRUMENT

    MDR report key: 3935235 · Received July 15, 2014

    Report

    Report Number
    2955842-2014-04272
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 17, 2014
    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, FAILURE ANALYSIS INVESTIGATION OBSERVED THAT ONE GRIP TIP WAS BENT INWARDS AT THE DISTAL END. AS A RESULT TIPS CAN NOT CLOSE COMPLETELY. EVIDENCE NOT CONCLUSIVE, BUT BENT DAMAGE MAY BE DUE TO LIKELY MISHANDLING/MISUSE. AN ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE INSTRUMENT'S GRIP TIPS EXHIBITED CARBIDE INSERT DAMAGE. THE CARBIDE INSERT WAS BROKEN ON THE BENT TIP AND MISSING A PIECE MEASURED AT .078 LONG. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE DAMAGE TO THE INSTRUMENT'S CARBIDE INSERT 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 DURING REPROCESSING OF THE LARGE NEEDLE DRIVER INSTRUMENT, IT WAS NOTED THAT THE TIPS OF THE INSTRUMENT DID NOT MEET. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413493 LARGE NEEDLE DRIVER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420006-08 M11131203 959

    Patients

    Seq Age Sex Outcome Treatment
    1