BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2552349 · Received April 29, 2012

    Report

    Report Number
    2955842-2012-00184
    Event Type
    Injury
    Date Received
    April 29, 2012
    Date of Event
    March 28, 2012
    Report Date
    January 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE SYSTEM LOGS WERE REVIEWED BY AN ISI TECHNICAL SUPPORT ENGINEER AND NO ERRORS WERE OBSERVED WHICH INDICATE THAT THERE WERE ISSUES WITH THE PSM ARMS. THE PSMS ARE INSTRUMENT ARMS LOCATED ON THE PATIENT CART THAT PROVIDE THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE ROOT CAUSE OF THE SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT IS CURRENTLY UNDETERMINED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN ADDITIONAL INFORMATION ABOUT THE EVENT, BUT THE CUSTOMER HAS YET TO PROVIDE FURTHER DETAILS. IF ADDITIONAL EVENT DETAILS BECOME AVAILABLE A FOLLOW UP MDV WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI GASTRIC BYPASS PROCEDURE THE SURGEON WAS UNABLE TO MOVE PATIENT SIDE MANIPULATOR (PSM) ARM 2 FROM THE SURGEON CONSOLE. AFTER RESTARTING THE SYSTEM, PSM ARM 2 WORKED FINE. AFTER 15 MINUTES OF OPERATION THE SURGEON LOST CONTROL OF PSM ARM 1, RESULTING IN DAMAGE TO THE PATIENT'S STOMACH. NO FURTHER INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

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