BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 4232682 · Received November 6, 2014

    Report

    Report Number
    2955842-2014-05622
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE PITCH DOWN CABLE BROKEN AT THE DISTAL CLEVIS HUB. THE BROKEN CABLE SEGMENTS THAT CONTAIN THE CRIMPS WERE 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 FOUND. ISI HAS CONDUCTED A DEVICE HISTORY RECORD (DHR) REVIEW FOR THIS DEVICE AND DID NOT FIND ANY NON-CONFORMANCES THAT WERE RELATED TO THIS REPORTED EVENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN PITCH DOWN CABLE, FOUND DURING FAILURE ANALYSIS EVALUATION COULD LIKELY 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 A DA VINCI SURGICAL PROCEDURE, A SNAPPED CABLE WAS IDENTIFIED ON THE PERMANENT CAUTERY SPATULA INSTRUMENT. THERE WERE NO REPORTS OF FRAGMENTS FALLING INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713726 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10131122 868

    Patients

    Seq Age Sex Outcome Treatment
    1