{ "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": "2955842-2013-03502", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120127", "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": "458812", "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": [ "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": "20250806", "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 SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "36 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Nausea", "Ascites" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345241", "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": "3726513", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO DEVELOPED A POST-OPERATIVE COMPLICATION AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE ON (B)(6), 2012 WITH A PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROID UTERUS. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED ON THE OPERATIVE REPORT FOR THE DA VINCI SI TOTAL HYSTERECTOMY PROCEDURE. AT THE END OF THE PROCEDURE, THE SURGEON STATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND THE PATIENT'S URINE WAS NOTED TO BE CLEAR. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL AND FLANK PAIN. A CT SCAN REVEALED MULTIPLE PELVIC COLLECTIONS. A FOLLOW-UP CT SCAN ON (B)(6) 2012, REVEALED AN UNCHANGED LEFT PELVIC FLUID COLLECTION, MODERATE TO HIGH-GRADE OBSTRUCTION OF THE LEFT URETER, AND NEW ASCITES. TWO DAYS LATER, THE PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND SOME NAUSEA. SHE DENIED HAVING DIFFICULTY URINATING, FLANK PAIN, DYSURIA, OR HEMATURIA. ON (B)(6) 2012, THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, AND LEFT STENT PLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE NOTED. ON (B)(6) 2012, A COMPARATIVE CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED ALMOST COMPLETE RESOLUTION OF ABDOMINAL ASCITES AND DECREASED SIZE OF THE LEFT-SIDED PELVIC ABSCESS COLLECTION. THERE WAS ALSO SLIGHT PERSISTENT LEFT HYDRONEPHROSIS ALTHOUGH RENAL FUNCTION WAS FOUND TO BE SYMMETRIC. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL IN STABLE CONDITION ON (B)(6) 2012. ABDOMINAL CT SCANS PERFORMED ON (B)(6) 2012 REVEALED DECREASED SIZE OF THE ABSCESS COLLECTION. ON (B)(6)2012, THE PATIENT'S LEFT STENT WAS REMOVED. AN ABDOMINAL CT SCAN PERFORMED ON (B)(6) 2012 REVEALED NO RESIDUAL ABSCESS WITHIN THE PELVIS OR ACUTE ABDOMINAL/PELVIC ABNORMALITIES." }, { "mdr_text_key": "11290317", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED DA VINCI SI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED A PELVIC ABSCESS AFTER UNDERGOING A DA VINCI SI TOTAL 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": "" } ] }