{ "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": "2955842-2013-03514", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120214", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "458087", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20130912", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INSTRMNTS, ACCESSIES & ESU." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "39 YR", "patient_sex": "", "patient_weight": "101", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pain", "Swelling" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345889", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3728717", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON (B)(6) 2013, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 DUE TO MENOMETRORRHAGIA, SEVERE DYSMENORRHEA AND CHRONIC BACKACHE. THE PATIENT'S MEDICAL RECORDS REPORT THAT THE RISKS, BENEFITS AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT, THERE WERE NO ANOMALIES NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND GOOD AND COMPLETE HEMOSTASIS WAS NOTED. PELVIC HEMOSTASIS WAS RE-AFFIRMED BY DROPPING THE GAS PRESSURES. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, A CYSTOSCOPY WAS PERFORMED. THE PATIENT'S BLADDER WAS FOUND TO BE NORMAL, AND BILATERAL URETERIC OPENINGS NOTED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. PER THE MEDICAL RECORDS, ON (B)(6) 2012 THE PATIENT PRESENTED TO THE EMERGENCY COMPLAINING OF ABDOMINAL PAIN. A CT SCAN PERFORMED REVEALED THAT THE PATIENT HAD FLUID COLLECTION THAT APPEARED TO COME FROM THE REGION OF THE DISTAL RIGHT URETER AND RIGHT SIDED MILD HYDRONEPHROSIS. THE PATIENT WAS READMITTED AND STARTED ON IV ANTIBIOTICS. A CT UROGRAM PERFORMED ON (B)(6) 2012 REVEALED URINE LEAKAGE IN THE PATIENT'S ABDOMEN. THE PATIENT UNDERWENT AN ULTRASOUND AND FLUOROSCOPICALLY GUIDED NEPHROSTOMY TUBE PLACEMENT PROCEDURE ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ATTEMPTED STENT PLACEMENT THROUGH A CYSTOSCOPY PROCEDURE; HOWEVER, THE PROCEDURE WAS UNSUCCESSFUL AND ON THE SAME DAY, THE PATIENT UNDERWENT AN OPEN RIGHT URETERAL REIMPLANT WITH PSOAS HITCH PROCEDURE. ACCORDING TO THE OP REPORT, ANASTOMOSIS OF THE PATIENT'S BLADDER WAS PERFORMED AND A J STENT WAS PLACED. AFTER COMPLETION OF THE PROCEDURE THE PATIENT'S URETER APPEARED TO BE PINK AND HEALTHY. THE PATIENT WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL. DURING THE PATIENT'S HOSPITALIZATION, A ROUTINE EXAMINATION FOUND THAT THE PATIENT'S PAIN WAS IMPROVING. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. A FOLLOW-UP RETROPERITONEAL ULTRASOUND ON (B)(6) 2012 SHOWED OTHERWISE UNREMARKABLE BLADDER, NO FLUID COLLECTIONS AND NO EVIDENCE OF HYDRONEPHROSIS." }, { "mdr_text_key": "11286875", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. 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 SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A URETER INJURY DURING A DA VINCI SI HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }