BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3800485 · Received May 8, 2014

    Report

    Report Number
    2955842-2014-02855
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT BOTH YAW PULLEYS EXHIBITED CHARRING AND LOCALIZED MELTING, BETWEEN THE GRIPS AT THE BASE. FURTHER INSPECTION CONFIRMED MATERIAL WAS MISSING. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE MISSING YAW PULLEY MATERIAL, FOUND DURING FAILURE ANALYSIS INVESTIGATION, COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI THORACIC SYMPATHECTOMY PROCEDURE, THERE WAS SPARKING AT THE TIP OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, AS WELL AS THE SCENT OF PLASTIC AND METAL, ARCING. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE 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
    277896 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10130814 707

    Patients

    Seq Age Sex Outcome Treatment
    1