DA VINCI SI SURGICAL SYSTEM
Report
- Report Number
- 2955842-2015-01350
- Event Type
- Death
- Date Received
- October 30, 2015
- Date of Event
- November 21, 2012
- Report Date
- October 13, 2015
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K081137
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION CAN BE FOUND IN DATE RECEIVED BY MFR, TYPE OF REPORTS, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, AND ADDITIONAL MFR NARRATIVE. AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM PLAINTIFF'S ATTORNEY ON 01/02/2017. ISI WAS PROVIDED WITH VARIOUS PATIENT MEDICAL RECORDS DATED BETWEEN (B)(6) 2012 AND (B)(6) 2013. AFTER UNDERGOING THE DA VINCI-ASSISTED LEFT NEPHRECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT DEVELOPED ACUTE RENAL FAILURE AND REQUIRED HEMODIALYSIS. IN ADDITION, THE PATIENT DEVELOPED POST-OPERATIVE PERITONEAL ASCITES, SEVERE ACUTE PANCREATITIS, AND LEUKOCYTOSIS. ON (B)(6) 2012, A VASCATH WAS PLACED ON THE PATIENT'S RIGHT COMMON FEMORAL VEIN FOR DIALYSIS. HOWEVER, ON (B)(6) 2012, THE PATIENT UNDERWENT VASCATH PLACEMENT ON THE LEFT FEMORAL VEIN SINCE THE VASCATH INITIALLY PLACED ON THE RIGHT COMMON FEMORAL VEIN WAS NOTED TO BE NON-FUNCTIONAL. ON (B)(6) 2012, THE PATIENT WAS ASSESSED FOR ACUTE TYPE II RESPIRATORY FAILURE, ANEMIA, AND QUESTIONABLE SEVERE SEPSIS WITH A QUESTIONABLE ABDOMINAL SOURCE. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ULTRASOUND GUIDED INSERTION OF PERMCATH PROCEDURE. THE PERMCATH WAS INSERTED INTO THE PATIENT'S LEFT INTERNAL JUGULAR VEIN WITHOUT DIFFICULTY. ON (B)(6) 2012, THE PATIENT COMPLAINED OF EPIGASTRIC/CHEST PAIN AND WAS NOTED TO HAVE SEVERE ACUTE PANCREATITIS AND ASCITES. THE PATIENT REPORTEDLY UNDERWENT A COUPLE OF PARACENTESIS PROCEDURES ON UNSPECIFIED DATES. ON (B)(6) 2013, THE PATIENT WAS EVALUATED FOR A PANCREATIC LEAK AND QUESTIONABLE CLOGGED PANCREATIC STENT. THE PLAN WAS FOR AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) WITH PANCREATIC STENT IN THE A.M. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE STILL UNKNOWN.
BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. 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. THE SYSTEM LOGS ALSO REVEAL THAT NO DA VINCI CLIP APPLIER INSTRUMENTS WERE USED DURING THE SURGICAL PROCEDURE. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN.
AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED LEFT NEPHRECTOMY PROCEDURE AND A UMBILICAL HERNIORRHAPHY ON (B)(6) 2012 FOR A LEFT RENAL NEOPLASM AND AN UMBILICAL HERNIA. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE WHICH RESULTED WITH HIS DEATH ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. PER THE OPERATIVE REPORT, THE FOLLOWING WAS NOTED AFTER DISSECTION WAS PERFORMED, AT THIS POINT, IT WAS DECIDED TO PROCEED WITH DIVISION OF THE RENAL ARTERY AND WITH ELEVATION OF THE SUTURE, THE ARTERY WAS CUT BETWEEN THE TWO CLIPS, BUT ON ELEVATION BLEEDING DEVELOPED POSTERIORLY, WHICH WAS CONTROLLED INITIALLY WITH THE MARYLAND BIPOLAR IN NON COAGULATION MODE AND ATTEMPTS WERE MADE TO PLACE A SINGLE CLIP IN THE MAIN RENAL ARTERY HOWEVER, THIS WOULD NOT HOLD AND BLEEDING IMMEDIATELY ENSUED. THE PATIENT WAS URGENTLY CONVERTED TO AN OPEN THROUGH A LEFT PARAMEDIAN INCISION AND THE AORTA WAS CONTROLLED WITH DIGITAL PRESSURE. APPROXIMATELY 900 CC OF BLOOD WAS LOST DURING THIS RAPID CONVERSION. IT WAS NOTED THAT THE LEFT RENAL ARTERY HAD AVULSED FROM THE AORTA. ANOTHER SURGEON SCRUBBED IN AND REPAIRED THE AVULSED LEFT RENAL ARTERY WITH MULTIPLE PLEDGETTED SUTURES. THE ESTIMATED BLOOD LOSS OF THE AORTIC REPAIR PROCEDURE WAS APPROXIMATELY ONE LITER. NO COMPLICATIONS WERE NOTED. AFTER REPAIR OF THE RENAL ARTERY INJURY WAS PERFORMED AND HEMOSTASIS WAS SECURED, THE ORIGINAL SURGEON COMPLETED THE LEFT NEPHRECTOMY. THE TOTAL BLOOD LOSS FOR THE PROCEDURE WAS 1500 CC WITH PLACEMENT INCLUDING 3,000 CC OF LACTATED RINGERS, 500 CC HESPEN, THREE UNITS OF PACKED CELLS AND 250 CC FROM THE CELL SAVER. URINE OUTPUT WAS OVER 300 CC. NO OTHER PATIENT MEDICAL RECORDS SUCH AS THE PATIENT'S DISCHARGE SUMMARY, AUTOPSY REPORT, OR DEATH CERTIFICATE WERE PROVIDED FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723564 | DA VINCI SI SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. | IS3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Death| L| R |