BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 5192125 · Received October 30, 2015

    Report

    Report Number
    2955842-2015-01347
    Event Type
    Death
    Date Received
    October 30, 2015
    Report Date
    September 30, 2015
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE ISI CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT SHE WAS INFORMED BY THE SITE'S CHAIR OF GYN/ONCOLOGY THAT THE PATIENT HAD SUSTAINED AN UNSPECIFIED THERMAL BOWEL INJURY. THE CHAIR OF GYN/ONCOLOGY DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND INDICATED THAT THE SITE WAS IN THE PROCESS OF PERFORMING AN INTERNAL INVESTIGATION. ON 11/18/2015, ISI CONTACTED THE CSR. THE CSR INDICATED THAT THE SITE WAS NOT WILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT DEPARTMENT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN OBTAINED FROM THE SITE REGARDING THE REPORTED EVENT. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT ALLEGEDLY PASSED AWAY ON POST-OPERATIVE DAY 5. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS STILL UNKNOWN.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THE DATE OF THE DA VINCI SURGICAL PROCEDURE IS UNKNOWN. IN ADDITION, THE CAUSE OF THE PATIENT'S DEATH AND THE DATE THE PATIENT PASSED AWAY ARE UNKNOWN. 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 HYSTERECTOMY PROCEDURE, THE PATIENT ALLEGEDLY PASSED AWAY ON POST-OPERATIVE DAY 5. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 5. NO FURTHER CLINICAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723609 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P9B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death