BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3251002 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02788
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    June 26, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION PROVIDED REGARDING THE REPORTED EVENT, AT THIS TIME INTUITIVE SURGICAL IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. ISI HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE SITE TO VERIFY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT A PATIENT INJURY OCCURRED DURING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS INJURED BY A PATIENT SIDE MANIPULATOR (PSM) ARM ON THE PATIENT SIDE CART. THE INJURY SUSTAINED BY THE PATIENT WAS LOCATED OUTSIDE OF THE PATIENT'S BODY AT THE ILIAC CREST. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352907 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 SURG SYS, INSTRUMENTS & ACCESS & ESU