BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM-LARGE CLIP APPLIER INSTRUMENT

    MDR report key: 3800443 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02853
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT ONE GRIP CABLE WAS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT STUCK OUT AT THE WRIST. THE OTHER GRIP CABLE WAS LOOSE DUE TO THE BROKEN CABLE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE BROKEN CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTIONS WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, BROKEN CABLES WERE IDENTIFIED ON THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE DEVICE WAS NOT USED ON A PATIENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT, AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277680 MEDIUM-LARGE CLIP APPLIER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420327-02 S10111103 723

    Patients

    Seq Age Sex Outcome Treatment
    1