BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3444272 · Received November 1, 2013

    Report

    Report Number
    2955842-2013-04957
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    October 5, 2012
    Report Date
    October 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR CERVICAL DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THE FOLLOW UP RADIOLOGY AND OPERATIVE REPORTS AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH A 1 MONTH HISTORY OF URINARY LEAKAGE AND A RECENT CYSTOSCOPY AND RETROGRADE PYELOGRAM SHOWED LEFT URETERAL BLOCKAGE. THERE WAS UNSUCCESSFUL CROSSING INTO THE BLADDER. A LEFT NEPHROSTOMY TUBE PLACED. A LEFT URETERAL INJURY WAS FOUND AT THE URETEROVESICAL JUNCTION. AN URETERAL RE-IMPLANTATION IS IN THE PLANNING STAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562014 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000, A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES