BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 5490703 · Received March 9, 2016

    Report

    Report Number
    2955842-2016-00145
    Event Type
    Injury
    Date Received
    March 9, 2016
    Report Date
    February 10, 2016
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THERE IS NO ALLEGATION AT THIS TIME THAT A SPECIFIC INSTRUMENT OR ACCESSORY MANUFACTURED BY INTUITIVE SURGICAL, INC. (ISI) CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SITE'S RISK MANAGEMENT DEPARTMENT CLAIMED THAT THE PATIENT MAY HAVE DEVELOPED POST-OPERATIVE BRAIN HEMORRHAGES RELATED TO POSSIBLE METALLIC EMBOLI. HOWEVER, THE CAUSE OF THE PATIENT'S ALLEGED AND UNCONFIRMED POST-OPERATIVE COMPLICATIONS IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE RISK MANAGEMENT DEPARTMENT OF THE HOSPITAL THAT A PATIENT, WHO IS ALSO A NEURO-RADIOLOGIST, UNDERWENT A DA VINCI-ASSISTED MITRAL VALVE REPAIR PROCEDURE ON AN UNSPECIFIED DATE IN 2008. THE PATIENT IS LOOKING INTO THE POSSIBILITY THAT HE DEVELOPED POST-OPERATIVE BRAIN HEMORRHAGES RELATED TO METALLIC EMBOLI. THE PATIENT'S MEDICAL HISTORY IS REPORTEDLY COMPLICATED AND POST-OPERATIVE MRI FINDINGS HAVE NOT BEEN CONFIRMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146064 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other