BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 739747 · Received July 21, 2006

    Report

    Report Number
    2955842-2006-00079
    Event Type
    Other
    Date Received
    July 21, 2006
    Date of Event
    June 22, 2006
    Report Date
    June 22, 2006
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONCLUDED THAT THE SYSTEM FAULTS EXPERIENCED BY THE CUSTOMER WERE ASSOCIATED WITH AN IOD PCA AND MSD PCA. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED IOD PCA AND MSD PCA. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODES) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE PATIENT INCISIONS WERE CLOSED AND THE SURGICAL PROCEDURE WAS RESCHEDULED FOR A LATER DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE BEGINNING OF THE SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED MULTIPLE SYSTEM POWER ON FAULTS. NO PATIENT HARM WAS REPORTED. THE PATIENT INCISIONS WERE CLOSED AND THE SURGICAL PROCEDURE WAS RESCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM KOG INTUITIVE SURGICAL, INC. IS1200 A4.3P6 S00419

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other