{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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(ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND BILATERAL PERIAORTIC AND PELVIC LYMPH NODE DISSECTION PROCEDURE FOR CERVICAL CANCER ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A URETERAL INJURY REQUIRING THE PATIENT TO UNDERGO A STENT IMPLANTATION AND REMOVAL, A CYSTOGRAM AND A CYSTOSCOPY. ON (B)(6) 2013, THE PATIENT EXPIRED DUE TO METASTATIC CERVICAL CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT AND FOLLOW-UP HOSPITAL MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DURING THE DA VINCI SURGICAL PROCEDURE AND THERE WAS NO INDICATION THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ACCORDING TO THE INFORMATION IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013, THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO FALLING AT HOME. DURING THE PATIENT'S HOSPITALIZATION THE PATIENT WAS FOUND TO BE ANEMIC, DEHYDRATED AND HAD WORSENING SYMPTOMS OF PARKINSON'S DISEASE. THE PATIENT WAS DIAGNOSED WITH ACUTE RENAL FAILURE FROM ADVANCING CERVICAL CANCER AND URETERAL COMPRESSION. A CYSTOSCOPY WAS PERFORMED WITH PLACEMENT OF A STENT. ON (B)(6) 2013 THE PATIENT WAS RE-ADMITTED INTO THE HOSPITAL DUE TO SEPSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2013 THE PATIENT EXPIRED. THE PATIENT'S DEATH CERTIFICATE INDICATED THAT THE PATIENT'S CAUSE OF DEATH WAS METASTATIC CERVICAL CANCER. NO FURTHER INFORMATION WAS PROVIDED." }, { "mdr_text_key": "19046512", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE URETERAL INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI SURGICAL PROCEDURE AND PASSED AWAY APPROXIMATELY 11 MONTHS LATER. HOWEVER, BASED ON THE INFORMATION INDICATED IN THE PATIENT'S CERTIFICATE OF DEATH, THE PATIENT'S DEMISE WAS DUE TO METASTATIC CERVICAL CANCER. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }