BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 4491732 · Received February 6, 2015

    Report

    Report Number
    2955842-2015-00250
    Event Type
    Death
    Date Received
    February 6, 2015
    Date of Event
    January 3, 2014
    Report Date
    January 7, 2015
    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

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NISSEN FUNDOPLICATION WITH REPAIR OF A HIATAL HERNIA AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2014 FOR A LARGE INCARCERATED HIATAL HERNIA WITH HISTORY OF BARRETT ESOPHAGUS, AND CHRONIC CHOLECYSTITIS AND CHOLELITHIASIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT, ADDITIONAL OPERATIVE REPORT, PROGRESS NOTES, AND AUTOPSY REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED IN THE DA VINCI SURGICAL PROCEDURE. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE PATIENT WAS EXTUBATED AND TRANSFERRED TO RECOVERY ROOM WITH STABLE VITAL SIGNS. THE ESTIMATED BLOOD LOSS FOR THE PROCEDURE WAS 75 CC. ON (B)(6) 2014, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH REPAIR OF A GASTRIC PERFORATION AND ABDOMINAL WASHOUT. THE OPERATIVE REPORT INDICATES THAT PATIENT HAD BEEN TOLERATING LIQUIDS AND WAS AMBULATORY AND AFEBRILE POST-OPERATIVELY FROM THE DA VINCI SURGICAL PROCEDURE. HOWEVER, ON (B)(6) 2014, THE PATIENT BECAME OLIGURIC WITH INCREASING CREATININE AND CONFUSION. A CT-SCAN REVEALED A LARGE AMOUNT OF FREE AIR AND FLUID IN THE ABDOMEN. THE PATIENT ALSO UNDERWENT REPAIR OF A VENTRAL HERNIA AND INSERTION OF BILATERAL CHEST TUBES. ACCORDING TO THE OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED PERITONITIS SECONDARY TO A 1 CM PERFORATION OF THE UPPER FUNDUS AT THE LEFT POSTEROLATERAL WALL ON THE LATERAL ASPECT OF THE WRAP. THE SURGEON NOTED, I PRESUME THAT THIS PERFORATION WAS EITHER AN INJURY FROM A GRASPER OR PERHAPS THE HARMONIC SCALPEL IN MOBILIZING THE GREATER CURVATURE AND SHORT GASTRICS IN PREPARATION FOR THE WRAP. THE SURGEON WAS ABLE TO OVERSEW THE PERFORATION AND NO OTHER LEAKS WERE FOUND. ACCORDING TO THE PATIENT'S AUTOPSY REPORT, THE CAUSE OF DEATH WAS COMPLICATIONS OF BACTERIAL SEPSIS DUE TO ACUTE GRAM-POSITIVE COCCI BACTERIAL PERITONITIS AND ABSCESS FORMATION WITH POSSIBLE GRAM-NEGATIVE DIPLOCOCCIC BACTERIAL PERITONITIS AND INFECTIOUS COMPLICATIONS OF SURGICAL THERAPY FOR HIATAL HERNIORRHAPHY. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATION OF THE UPPER FUNDUS AND SUBSEQUENTLY PASSED AWAY FROM BACTERIAL SEPSIS.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT 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) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AN ATTORNEY CLAIMED THAT THE PATIENT SUSTAINED A PERFORATION WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE, DEVELOPED BACTERIAL SEPSIS, AND SUBSEQUENTLY EXPIRED. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE IS 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 CHOLECYSTECTOMY ON (B)(6) 2014 AND SUSTAINED AN INTRA-OPERATIVE PERFORATION. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT PASSED AWAY ON (B)(6) 2014 DUE TO COMPLICATIONS OF BACTERIAL SEPSIS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87463 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L