BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI

    MDR report key: 8380462 · Received February 28, 2019

    Report

    Report Number
    2955842-2019-10148
    Event Type
    Death
    Date Received
    February 28, 2019
    Date of Event
    November 20, 2017
    Report Date
    February 15, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF¿S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED AN ESOPHAGEAL PERFORATION WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, DEVELOPED POST-OPERATIVE SYMPTOMS, AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT¿S ALLEGED OPERATIVE COMPLICATIONS AND SUBSEQUENT DEATH 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 ¿ADHESIOLYSIS AND REDUCTION OF A SLIPPED NISSEN WITH COMPLETION LAPAROTOMY, REPAIR OF HIATAL HERNIA AND REDO OF NISSEN FUNDOPLICATION¿ PROCEDURE ON (B)(6) 2017. THE PLAINTIFFS¿ ATTORNEY ALLEGES THAT THE PATIENT ¿EXPERIENCED COMPLICATIONS DURING THE SURGERY, NAMELY ISSUES WITH THE PATIENT¿S BLOOD PRESSURE AND OXYGENATION WHEN HE INCREASED THE PRESSURE OF THE GAS INSUFFLATING THE PATIENT¿S ABDOMINAL WALL.¿ THE PLAINTIFFS¿ ATTORNEY NOTED THAT WHEN THE PRESSURE WAS DECREASED, THE SURGEON¿S ¿VISIBILITY ALSO DECREASED, LEADING HIM TO UNDOCK THE ROBOT AND CONVERT THE OPERATION TO AN OPEN SURGERY.¿ AT AN UNSPECIFIED TIME DURING THE SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN ¿ESOPHAGEAL PERFORATION RESULTING IN THE LEAKAGE OF STOMACH CONTENTS INTO HER MEDIASTINUM.¿ AS A RESULT, THE PATIENT EXPERIENCED ¿IMMEDIATE RESPIRATORY COMPLICATIONS INCLUDING ATELECTASIS, PLEURAL FLUID AND PNEUMONIA, AND EVENTUALLY TO SEPSIS.¿ THE PATIENT ALLEGEDLY EXPERIENCED ¿PAIN AND SUFFERING¿ FROM (B)(6) 2017. DURING THIS TIME, THE PATIENT REPORTEDLY HAD ¿THE INABILITY TO BREATH ON HER OWN AND NEEDED AN ENDOTRACHEAL TUBE DOWN HER THROAT MAKING IT DIFFICULT IF NOT IMPOSSIBLE TO SPEAK AND TO EAT, SEVERE CHEST AND BACK PAIN RESULTING FROM THE AIR AND FLUID IN HER CHEST CAUSING HER LUNG TO COLLAPSE, A LONG TERM INTUBATION PERIOD, A PICC LINE, DIALYSIS, YEAST AND BACTERIAL INFECTIONS, AND TUBE FEEDING.¿ THE PATIENT ALLEGEDLY EXPIRED ON (B)(6) 2017 FROM COMPLICATIONS FROM THE SURGERY. 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
    173648 DA VINCI DA VINCI XI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R