BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3345222 · Received September 12, 2013

    Report

    Report Number
    2955842-2013-03499
    Event Type
    Death
    Date Received
    September 12, 2013
    Date of Event
    January 23, 2012
    Report Date
    August 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE DEMISE OF THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED PRIOR TO THE PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPIRED PRIOR TO A PLANNED DA VINCI SI SURGICAL PROCEDURE. AT THIS TIME, THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO EXPIRED AT THE BEGINNING OF A PLANNED DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. AT THE TIME OF THE EVENT, THE DA VINCI SI SYSTEM HAD NOT YET BEEN DOCKED TO THE PATIENT. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE LEIOMYOMA, REFRACTORY TO MEDICAL MANAGEMENT. ACCORDING TO THE OPERATIVE NOTE, THE GENERAL ENDOTRACHEAL ANESTHESIA WAS ESTABLISHED PRIOR TO STARTING THE SURGICAL PROCEDURE. THE SURGEON MADE A HORIZONTAL INCISION IN THE PATIENT'S UMBILICUS WITH A SCALPEL AND A VERESS NEEDLE WAS USED TO ACCESS THE ABDOMINAL CAVITY. AFTER THE PATIENT'S ABDOMEN WAS INSUFFLATED WITH APPROXIMATELY 3 L OF CARBON DIOXIDE GAS, THE VERESS NEEDLE WAS REMOVED AND A 12 -MM TROCAR WAS PLACED. THE SURGEON STATED THAT AN EXPLORATION OF THE ABDOMEN AND PELVIS WAS PERFORMED AND NO EVIDENCE OF ANY INJURY AT THE SITE OF ENTRY WAS FOUND. THE PATIENT WAS THEN PLACED IN TRENDELENBURG POSITION. DURING REPOSITIONING, THE PATIENT WAS NOTED TO HAVE INTERMITTENT HYPOTENSION AND HYPERTENSION. HOWEVER, THE SURGEON STATED THAT IT WAS SAFE TO PROCEED WITH THE PROCEDURE. AN 8-MM INCISION WAS MADE IN THE LEFT LOWER QUADRANT AND A DA VINCI TROCAR WAS INTRODUCED UNDER DIRECT VISUALIZATION. AT THAT POINT, THE PATIENT WAS NOTED TO HAVE AN EXTREMELY LOW BLOOD PRESSURE WITH A SYSTOLIC CUFF READING OF 40. THE PATIENT WAS IMMEDIATELY RETURNED TO SUPINE POSITION, THE ABDOMEN WAS DESUFFLATED, AND THE TROCARS WERE REMOVED. THE PATIENT WAS FOUND TO HAVE NO FEMORAL PULSE AND CPR WAS INITIATED. AFTER 1 HOUR OF ATTEMPTED RESUSCITATION WITH THE ASSISTANCE OF A CARDIOVASCULAR SURGEON, THE PATIENT'S CODE ARREST WAS CALLED IN THE OR. ACCORDING TO THE PRELIMINARY AUTOPSY REPORT, THERE WAS NO GROSS ANATOMICAL ETIOLOGY FOR CARDIAC ARREST. PER THE ATTENDANT CARDIOVASCULAR SURGEON, THERE WAS NO MYOCARDIAL INFARCTION, PULMONARY EMBOLISM, ACUTE BLOOD LOSS, CARDIAC TAMPONADE, OR TENSION PNEUMOTHORAX. ACCORDING TO THE PATIENT'S FINAL AUTOPSY REPORT, THE PATIENT'S BODY WAS FOUND TO BE OPEN BY MEANS OF A CUSTOMARY Y-SHAPED INCISION FROM THE SHOULDERS TO THE PUBIS. IN RELATION TO RESUSCITATION EFFORTS, AREAS OF VERY MILD FRESH HEMORRHAGE WERE FOUND TO BE PRESENT IN THE UPPER ANTERIOR MEDIASTINAL FAT. THE ENTIRE GASTROINTESTINAL TRACT WAS FOUND TO BE COMPLETELY UNREMARKABLE. INSPECTION OF THE ABDOMEN REVEALED NO ACIDIC FLUID OR AREAS OF FRESH OR OLD HEMORRHAGE. IN REGARDS TO THE PATIENT'S RESPIRATORY SYSTEM, THE PLEURAL SPACES WERE FOUND TO BE INTACT AND THERE WAS NO EVIDENCE OF TRAUMA OR INFARCTION. IN REFERENCE TO THE PATIENT'S CARDIOVASCULAR SYSTEM, THE PERICARDIAL SAC WAS COMPLETELY FREE OF EXCESS FLUID OR HEMORRHAGE. THERE WAS NO SUGGESTION OF TAMPONADE. IN ADDITION, THE CORONARY ARTERIES WERE COMPLETELY FREE OF ATHEROSCLEROTIC CHANGE AND THERE WAS NO SUPERIMPOSED THROMBOEMBOLIC EFFECT. THE AORTA WAS FREE OF ATHEROSCLEROTIC CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458715 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES