BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3232533 · Received July 18, 2013

    Report

    Report Number
    2955842-2013-02587
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 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 ON (B)(4) 2013. ENGINEERING NOTED A BROKEN DISTAL CLEVIS, BROKEN CABLES, AND A MISSING YAW PULLEY. THE INSTRUMENT WAS RETURNED WITH BOTH DISTAL CLEVIS EARS BROKEN OFF AT THEIR BASE. BROKEN PIECES WERE NOT RETURNED, BUT WERE ROUGHLY 0.285 X 0.220 IN SIZE. YAW PULLEY AND HOOK WERE MISSING FROM THE DISTAL END. YAW CABLES HAVE ALL BEEN CUT, ALLOWING DETACHMENT OF YAW PULLEY. EVIDENCE NOT CONCLUSIVE, BUT CLEVIS BREAKAGE IS LIKELY DUE TO OVERLOADING THE TIP. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE OBSERVATIONS FOUND DURING FAILURE ANALYSIS COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF TO REOCCUR.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED INTUITIVE SURGICAL, INC. ABOUT THE PERMANENT CAUTERY HOOK INSTRUMENT BUT NO DESCRIPTION OF THE INSTRUMENT WAS PROVIDED. NOTHING REPORTEDLY FELL 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
    334965 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-05 M10101202 446

    Patients

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