BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 6547776 · Received May 5, 2017

    Report

    Report Number
    2955842-2017-00276
    Event Type
    Death
    Date Received
    May 5, 2017
    Date of Event
    March 27, 2015
    Report Date
    April 11, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE FOLLOWING INFORMATION IS UNKNOWN: WHAT SPECIFIC OPERATIVE DAMAGES THE PATIENT SUSTAINED, AND WHAT THE ROOT CAUSES WERE FOR THE ALLEGED OPERATIVE DAMAGES, CARDIOPULMONARY FAILURE, POST-OPERATIVE BLEEDING, AND DEATH. IN ADDITION, THE NAME OF THE FACILITY WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. LIKEWISE, THE NAME OF THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE, SUSTAINED UNSPECIFIED DAMAGES, EXPERIENCED POST-OPERATIVE COMPLICATIONS, AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE ALLEGED OPERATIVE COMPLICATIONS ARE UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2015 AND ALLEGEDLY SUSTAINED UNSPECIFIED DAMAGES. THE PLAINTIFF'S ATTORNEY CLAIMED THAT IMMEDIATELY FOLLOWING SURGERY, THE PATIENT DEVELOPED A CARDIOPULMONARY FAILURE AND SUFFERED FROM BLEEDING WHICH LED TO HER DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329494 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L| R