BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 3251003 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02803
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    September 18, 2012
    Report Date
    June 28, 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 LIMITED INFORMATION PROVIDED IN THE LEGAL COMPLAINT, INTUITIVE SURGICAL, INC. IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2012, SUSTAINED AN INTRA-OPERATIVE THERMAL BURN TO THE BLADDER, RESULTING IN A LACERATION THAT REQUIRED THE PLACEMENT OF A FOLEY CATHETER AND FURTHER HOSPITALIZATION. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT REQUIRED AN INTRA-OPERATIVE PLACEMENT OF A TRANSOBTURATOR TAPE (BLADDER SLING) WHICH CAUSED EROSION OF THE PATIENT'S VAGINAL MESH, REQUIRING THE PATIENT TO UNDERGO TWO SUBSEQUENT SURGICAL PROCEDURES. PER THE INFORMATION INDICATED IN THE LEGAL COMPLAINT, THE PATIENT CONTINUES TO SUFFER FROM CHRONIC VAGINAL PAIN AND INCONTINENCE, THUS REQUIRING THE PATIENT TO WEAR BLADDER PADS. THE PATIENT ALSO REQUIRES FURTHER BLADDER RECONSTRUCTIVE SURGERY AND URETERAL RE-IMPLANTATION. REPORTEDLY DUE TO THE INJURY SUSTAINED BY THE PATIENT DURING THE SURGICAL PROCEDURE, THE PATIENT HAS UNDERGONE AND CONTINUES TO UNDERGO MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS AND PROCEDURES, PHYSICIAN CONSULTATIONS AND ADDITIONAL SURGERIES. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS AND PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352840 DA VINCI SURGICAL SYSTEM ENDOSCOPIC ELECTROSURGICAL INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SURG SYS., INSTRUMENTS, ACCESSORIES & ES