DA VINCI SURGICAL SYSTEM
Report
- Report Number
- 2955842-2015-01168
- Event Type
- Death
- Date Received
- September 3, 2015
- Date of Event
- November 4, 2013
- Report Date
- August 11, 2015
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K081137
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED 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. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY ALLEGES THAT A DA VINCI SURGICAL SYSTEM INJURED THE PATIENT, CAUSED UNDIAGNOSED UTERINE CANCER TO SPREAD THROUGHOUT THE PATIENT'S BODY, AND CONTRIBUTED TO THE PATIENT SUBSEQUENT DEMISE A YEAR LATER.
AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND COMPLETE PELVIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2013 FOR STAGE 1B1 SQUAMOUS CELL CARCINOMA OF THE CERVIX. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE DA VINCI SURGICAL SYSTEM INJURED THE PATIENT AND SPREAD UNDIAGNOSED UTERINE CANCER THROUGHOUT THE PATIENT'S BODY. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 100 CC. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, AND (B)(6) 2014, THE PATIENT UNDERWENT A CT-SCAN OF HER ABDOMEN AND PELVIS. THE IMPRESSION FROM (B)(6) 2013 CT-SCAN SHOWED NO DEFINITIVE EVIDENCE OF METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 INCLUDED NEW CARCINOMATOSIS AND OMENTAL CAKING CONSISTENT WITH NEW METASTATIC DISEASE, AND A FEW SMALL LYMPH NODES IN THE UPPER ABDOMEN CONSISTENT WITH METASTATIC DISEASE. ON (B)(6) 2013, (B)(6) 2014, THE PATIENT UNDERWENT PET/CT SCANS. THE IMPRESSION OF THE (B)(6) 2013 PET-CT EXAM REVEALED NO EVIDENCE FOR HYPERMETABOLIC METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 PET/CT EXAM REVEALED FINDINGS CONSISTENT WITH NEW METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 PET/CT EXAM REVEALED A STABLE EXAMINATION WITH NO EVIDENCE FOR INTRATHORACIC, ABDOMINAL, OR PELVIC METASTATIC DISEASE. THE IMPRESSION FROM (B)(6) 2014 REVEALED SIGNIFICANT PROGRESSION OF OMENTAL CARCINOMATOSIS SINCE (B)(6) 2014. THE PATHOLOGY REPORT FROM (B)(6) 2013 NOTED THE FOLLOWING, INVASIVE POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA OF UTERINE CERVIX; EXTENSIVE LYMPHOVASCULAR INVASION PRESENT, WITH LYMPHOVASCULAR INVASION PRESENT, WITH LYMPHOVASCULAR INVASION PRESENT IN RIGHT PARAMETRIAL SOFT TISSUE; AND SEVERA SQUAMOUS DYSPLASIA/SQUAMOUS CELL CARCINOMA IN-SITU (CIN3) AT CERVICAL TRANSFORMATION ZONE. PER THE DEATH CERTIFICATE, THE PATIENT PASSED AWAY ON (B)(6) 2014 FROM METASTATIC CERVICAL CANCER. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583651 | DA VINCI SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. | IS3000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Death |