BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPSINSTRUMENT

    MDR report key: 3180752 · Received June 20, 2013

    Report

    Report Number
    2955842-2013-02241
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND THE PITCH CABLE WAS BROKEN AT THE INSTRUMENT'S WRIST. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. AN ADDITIONAL OBSERVATION WAS A RECOGNITION PROBLEM. THE INSTRUMENT WAS PLACED ON SYSTEM FOR TESTING AND WAS NOT RECOGNIZED. THE SYSTEM FAILED TO RECOGNIZE THE INSTRUMENT ON MULTIPLE INSTALLATION ATTEMPTS. A LAPTOP CONNECTED TO THE SYSTEM SHOWED THAT THE DALLAS CHIP WAS NOT BEING SENSED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN 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

    A FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS RETURNED WITHOUT ANY EVENT INFORMATION. NO COMPLAINT WAS COMMUNICATED TO INTUITIVE SURGICAL REGARDING PERFORMANCE OF THE DA VINCI SURGICAL SYSTEM. NO MALFUNCTION OF THE DA VINCI SYSTEM WAS ALLEGED THERE WERE NO MISSING PIECES OR FALLEN PIECES REPORTED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280136 FENESTRATED BIPOLAR FORCEPSINSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130115 429

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYSTEM INSTRUMENTS & ACCESSORIES ESU