BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3430582 · Received October 25, 2013

    Report

    Report Number
    2955842-2013-04652
    Event Type
    Injury
    Date Received
    October 25, 2013
    Report Date
    October 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE INTERNET POSTING DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THE MEDICAL CENTER NAME, SYSTEM SERIAL , AND PATIENT CONTACT INFORMATION INVOLVED WITH THIS COMPLAINT ARE UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE SUSTAINED A HERNIA AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE DETAILS OF THE PATIENT'S INJURY ARE NOT KNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A (B)(4) DATED (B)(4) 2013 AND TITLED, TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! THE INTERNET POSTING CONTAINED THE FOLLOWING EVENT DESCRIPTION: TROUBLE STILL WITH INCISION AREA AFTER BOTCHED DAVINCI SURGERY. FINALLY MY SURGEON ORDERED A CT SCAN AND SURE ENOUGH ... I HAVE A HERNIA! I HAVE TO HAVE SURGERY AGAIN!!!! ANYONE ELSE GET HERNIA AFTER HYSTERECTOMY? WEB LINK: HTTPS://WWW.WHATNEXT.COM/QUESTIONS/TROUBLE-STILL-WITH-INCISION-AREA-AFTE R-BOTCHED-DAVINCI-SURGERY-FINALLY-MY-SURGEON-ORDERED-A-C T-SCAN-AND-SURE-ENOUGH-I-HAVE-A-HERNIA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548935 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE