BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3913857 · Received July 3, 2014

    Report

    Report Number
    2955842-2014-04079
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    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 OF THE POST SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE WAS NO ALLEGATION BY THE HOSPITAL THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE PLANNED PROCEDURE. ISI HAS CONTACTED THE HOSPITAL'S RISK MANAGEMENT TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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: POST A DA VINCI GYN PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S URETER WAS DAMAGED, REQUIRING THE PATIENT TO UNDERGO CORRECTIVE SURGERY TO REPAIR THE DAMAGE. HOWEVER, AT THIS TIME THE CAUSE OF THE PATIENT'S URETERAL INJURY IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DA VINCI GYN PROCEDURE ON AN UNSPECIFIED DATE, IT WAS DISCOVERED THAT THE PATIENT SUSTAINED AN INJURY TO HER URETER. THE PATIENT UNDERWENT CORRECTIVE SURGERY TO HAVE THE DAMAGE TO HER URETER REPAIRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389951 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention