BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 2923484 · Received January 22, 2013

    Report

    Report Number
    2955842-2013-00251
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 20, 2012
    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. COMPLAINT OF BROKEN HOUSING CANNOT BE CONFIRMED. HOUSING SNAPS ARE INTACT AND UNDAMAGED. HOUSING CANNOT BE LIFTED UP FROM CHASSIS. NO CRACKING DAMAGE OBSERVED ON HOUSING. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE ARE A BROKEN DISTAL CLEVIS, MISSING CONDUCTOR CAP, AND BROKEN BANANA PLUG. INSTRUMENT WAS RETURNED WITH ONE DISTAL CLEVIS EAR BROKEN OFF AT ITS BASE. CLEVIS EAR ON SIDE OPPOSITE CONDUCTOR WIRE IS BROKEN OFF, RESULTING IN DISLODGMENT OF YAW PULLEY. BROKEN PIECE WAS NOT RETURNED, BUT IS ROUGHLY .285 X .220 IN SIZE. CONDUCTOR CAP LIKELY DETACHED AS A RESULT OF CLEVIS EAR BREAKAGE. YAW PULLEY BOSS FEATURE ON CONDUCTOR WIRE SIDE THAT MATES WITH CAP IS BROKEN OFF. EVIDENCE NOT CONCLUSIVE, BUT BREAKAGE IS LIKELY DUE TO OVERLOADING THE TIP. BANANA PLUG IS CRACKED AT THE TIP AND THE SPRING FEATURES ARE NO LONGER FORMED CORRECTLY AS A RESULT. A MONOPOLAR CORD CANNOT BE INSTALLED ON PLUG DUE TO DAMAGE. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, DURING SET UP, THE SURGICAL STAFF REPORTED SEEING BROKEN HOUSING ON THE PERMANENT CAUTERY SPATULA INSTRUMENT. NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29970 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10120817 944

    Patients

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