BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY SPATULA INSTRUMENT

    MDR report key: 3232543 · Received July 18, 2013

    Report

    Report Number
    2955842-2013-02588
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 18, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE. THE INSTRUMENT DID NOT EXHIBIT ANY BENT COMPONENTS UPON VISUAL INSPECTION. INSTRUMENT'S BANANA PLUG LOCATED ON THE BLUE HOUSING WAS STRAIGHT. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A BROKEN YAW PULLEY FEATURE. ONE OF THE BOSS FEATURES AT THE PULLEY HUB WAS PROTRUDING ABOVE THE DISTAL CLEVIS. FURTHER INSPECTION SHOWED THAT THE BOSS WAS BROKEN AT ITS BASE AND COULD BE PULLED OUT OF THE CLEVIS. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE BROKEN YAW PULLEY FOUND DURING FAILURE ANALYSIS IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CLEANING AND STERILIZATION, THE CUSTOMER NOTED THAT THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS BENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333491 PERMANENT CAUTERY SPATULA INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420184-06 M10120323 235

    Patients

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