BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1810273 · Received August 20, 2010

    Report

    Report Number
    2955842-2010-00377
    Event Type
    Other
    Date Received
    August 20, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT THE CUSTOMER REPORTED COMPLAINT WAS RELATED TO THE PATIENT SIDE POWER DISTRIBUTION (PPD) PCS BOARD. THE PATIENT SIDE POWER DISTRIBUTION BOARD IS A PRINTED CIRCUIT (PCA) BOARD LOCATED ON THE PATIENT SIDE CART THAT DIVIDES THE ELECTRICAL POWER FEED INTO SUBSIDIARY CIRCUITS WHILE PROVIDING A PROTECTIVE CIRCUIT BREAKER FOR EACH CIRCUIT. THE SYSTEM WAS REPAIRED BY REPLACING THE PPD. AS OF (B)(6) 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING TO START A DA VINCI S EPICARDIAL ABLATION PROCEDURE, UPON POWERING UP THE SYSTEM, THE SITE EXPERIENCED SYSTEM ERROR CODE 3. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER THE SITE POWER CYCLED THE SYSTEM, HOWEVER UPON RESTART THE PATIENT SIDE CART BATTERY LEDS WERE RED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SYS, INSTRUMENTS, ACCESSORIES AND ESU