BASED ON THE INFORMATION PROVIDED THE CAUSE OF THE REPORTED DEATH IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS MADE ADDITIONAL ATTEMPTS TO CONTACT THE SITE AND GATHER PATIENT INFORMATION. HOWEVER, THE SITE WAS UNWILLING TO PROVIDE ADDITIONAL INFORMATION AS OF THE DATE OF THIS REPORT. ISI HAS REVIEWED THE SITE?S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2019. THERE WERE NO ERRORS OR EVENT IN THE LOGS THAT ARE CONSISTENT WITH A PRODUCT ISSUE RELATED TO THE REPORTED COMPLAINT. IT WAS CONFIRMED ALL THE INSTRUMENTS USED DURING THIS PROCEDURE HAVE BEEN USED IN SUBSEQUENT PROCEDURES. AS PER THE SYSTEM LOGS, THE STAPLER 45 INSTRUMENT HAD SUCCESSFUL FIRES WITH 2 GREEN STAPLER 45 RELOADS. THEN THE STAPLER 30 INSTRUMENT COMPLETED 1 FIRE WITH A WHITE STAPLER 30 RELOAD; HOWEVER, THIS FIRE WAS COMPLETED AFTER 4 INCOMPLETE CLAMPS OUT OF 5 ATTEMPTS. AFTER THE SUCCESSFUL FIRE OF THE WHITE STAPLER 30 RELOAD, THERE WAS A SUBSEQUENT INSTALL OF THE STAPLER 30 INSTRUMENT WHERE A CLAMP WAS ABORTED AND THE INSTRUMENT SUCCESSFULLY UNCLAMPED WITH NO ATTEMPT TO FIRE THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, UNSPECIFIED COMPLICATIONS OCCURRED WHILE THE SURGEON WAS DISSECTING THE TUMOR. DURING THE PROCESS OF CONVERTING TO OPEN SURGERY, THE PATIENT EXPIRED. HOWEVER, THE SURGEON INDICATED THAT THE COMPLICATIONS WOULD HAVE LIKELY OCCURRED EVEN IF THE SURGICAL PROCEDURE WAS PERFORMED VIA VATS.
D
Patient 1
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, UNSPECIFIED COMPLICATIONS OCCURRED WHILE THE SURGEON WAS DISSECTING THE TUMOR. DURING THE PROCESS OF CONVERTING TO OPEN SURGERY, THE PATIENT EXPIRED. ON 18-JUN-2019 AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS CONTACTED BY THE SITE'S ROBOTICS COORDINATOR WHO INFORMED THE CSR OF THE EVENT THAT HAPPENED ON (B)(6) 2019. THE CSR WAS NOT PRESENT DURING THE CASE. THE CSR THEN CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AT THAT TIME THE SURGEON INDICATED TO THE CSR THAT THE DA VINCI SURGICAL SYSTEM WAS IN NO WAY AT FAULT FOR THE INTRA-OPERATIVE COMPLICATION AND THE PATIENT'S SUBSEQUENT PASSING. THE SURGEON ALSO STATED THAT THE COMPLICATION WOULD HAVE LIKELY OCCURRED EVEN IF THE PROCEDURE WAS PERFORMED VIA VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS.) THERE WAS NO ALLEGATION FROM THE SURGEON THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON (B)(6) 2020, THE CSR CONFIRMED THAT THE PATIENT WAS A (B)(6) YEAR OLD, WHITE MALE, WEIGHING (B)(6) LBS. THE SITE WAS NOT WILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE CAUSE OF DEATH OR AUTOPSY RESULTS.