{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-04920", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "562320", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Insufficient Device Problem Information" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131101", "sequence_number_treatment": [ "DA VINCI SI SURG SYS, INSTRMNTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "55", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Extravasation", "Injury", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444169", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "3781896", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY WITH PELVIC AND PARA-AORTIC LYMPH NODE SAMPLING, URETEROLYSIS, AND CYSTOSCOPY WITH STENT PLACEMENT ON (B)(6) 2010. THE PATIENT WAS DIAGNOSED WITH STAGE IB-1 CERVICAL ADENOSQUAMOUS CARCINOMA. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL EXAM, PATHOLOGY REPORTS, DISCHARGE SUMMARY, SUBSEQUENT OPERATIVE NOTES FROM UROLOGY, UROLOGY CONSULTATIONS AND HOSPITAL DISCHARGE SUMMARIES. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2010, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN AND WAS ADMITTED FOR EVALUATION AND WAS FOUND TO HAVE A LEFT URETERAL INJURY. A PERITONEAL FLUID COLLECTION WAS DRAINED ON (B)(6) 2010, A LEFT PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED, CT AND X-RAYS WERE OBTAINED AND A RETROGRADE UROGRAM WAS PERFORMED. THE PATIENT THEN WENT TO SURGERY WHERE A CYSTOSCOPY, A NEPHROSTOGRAM, AND A URETEROURETEROSCOPY WERE PERFORMED. THE PATIENT WAS FOUND TO HAVE THE LEFT URETER BLOCKED AT THE PELVIC BRIM WITH EXTRAVASATION OF URINE INTO THE RETROPERITONEUM. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO A HOSPITAL AND UNDERWENT A LAPAROTOMY WITH A LEFT URETERAL REIMPLANTATION PERFORMED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 IN STABLE CONDITION TO HOME. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE." }, { "mdr_text_key": "11252660", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. THE PATIENT UNDERWENT A RADICAL HYSTERECTOMY FOR ADVANCED CERVICAL CANCER. ISI'S REVIEW OF THE PATIENT'S OPERATIVE REPORT FOUND NO EVIDENCE OF CAUTERY INJURY TO THE PATIENT'S URETER AT THE PELVIC BRIM. THERE ARE OTHER THEORIES THAT MIGHT APPLY TO EXPLAIN THE APPARENT INJURY TO THE LEFT URETER INCLUDING DIRECT TRAUMA TO THE URETER AND DEVASCULARIZATION DURING URETEROLYSIS. THE PATIENT EXPERIENCED KNOWN COMPLICATIONS FROM THIS TYPE OF CANCER SURGERY. THEY WERE TREATED IN A TIMELY MANNER AND THERE IS NO EVIDENCE TO SUPPORT ANY THEORY OF A DA VINCI RELATED MALFUNCTION WAS IN THIS CASE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S LEFT URETER WAS DAMAGED DURING A DA VINCI SI HYSTERECTOMY WITH PELVIC AND PARA-AORTIC LYMPH NODE SAMPLING, URETEROLYSIS, AND CYSTOSCOPY WITH STENT PLACEMENT." } ], "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": "" } ] }