{ "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": "2955842-2013-04006", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120426", "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": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502408", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "brand_name": "DA VINCI S 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": "IS2000 A5.1P7", "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": "20250824", "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": "20131004", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Peritonitis" ] } ], "distributor_city": "", "date_report": "20130905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388746", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130905", "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": "19563335", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. PRIOR TO THE DA VINCI S SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS OF THE SURGERY AND CONSENT WAS OBTAINED. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS SYMPTOMATIC UTERINE FIBROIDS. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI S HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED COMPLICATIONS. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. SHE WAS DISCHARGED HOME FROM THE HOSPITAL ON POST-OPERATIVE DAY 1 ((B)(6) 2012). THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI S SYSTEM, AN INSTRUMENT, OR AN ACCESSORY IN THE OPERATIVE REPORT. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR A REPORTED COMPLAINT OF ABDOMINAL PAIN AND DIAGNOSED WITH PNEUMOPERITONEUM. THAT SAME DAY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND DRAINAGE OF A PELVIC ABSCESS. THE PATIENT ALSO UNDERWENT AN INCIDENTAL APPENDECTOMY DUE TO PERIAPPENDICITIS. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED ON THE OPERATIVE REPORT. A GYNECOLOGIST WAS CALLED IN DURING THE PROCEDURE TO CHECK THE PELVIS. THE CUFF WAS HEALING WELL. NO EVIDENCE OF ANY RESIDUAL PROBLEMS WAS FOUND FROM HER PREVIOUS ROBOTIC ASSISTED HYSTERECTOMY. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2012, AFTER RECOVERING FROM PROLONGED POST-OPERATIVE ILEUS CONSISTENT WITH HER PERITONITIS. ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL AND WAS ADMITTED WITH FOR ABDOMINAL PAIN, NAUSEA, VOMITING, AND SUSPECTED ILEUS. THE PATIENT WAS REHYDRATED AND HER ELECTROLYTE ABNORMALITIES WERE ADJUSTED. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY AFTER HER ILEUS WAS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED SINCE THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2012." }, { "mdr_text_key": "19793198", "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 FOR THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. 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 PLANNED 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 S 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": "" } ] }