BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    MDR report key: 3863978 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03548
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND A LOOSE PITCH CABLE DUE TO ANOTHER PITCH CABLE AT THE TIP WAS BROKEN. ADDITIONAL OBSERVATION NOR REPORTED WAS A BROKEN PITCH UP CABLE AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE FOUND DURING FAILURE ANALYSIS COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, A LOOSE CABLE WAS IDENTIFIED ON A DOUBLE FENESTRATED GRASPER INSTRUMENT. THERE WAS NO ALLEGATION OF HARM OR INJURY TO A PATIENT. NOTHING REPORTEDLY FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339054 DOUBLE FENESTRATED GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420189-09 M10131108 851

    Patients

    Seq Age Sex Outcome Treatment
    1