{ "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": "2955842-2013-05004", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131102", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110706", "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": "565289", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131102", "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": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20131102", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "41 YR", "patient_sex": "", "patient_weight": "66", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Vomiting", "Obstruction/Occlusion", "Abdominal Distention", "Constipation" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444683", "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": "20176073", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "20005716", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ROBOTIC LEFT OOPHORECTOMY , RIGHT OVARIAN CYST DRAINAGE, AND EXCISION OF RIGHT PARATUBAL CYST FOR CHRONIC PAIN ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH DA VINCI ROBOTIC LAPAROSCOPIC REMOVAL OF LEFT OVARY, LYSIS OF ADHESIONS AND RIGHT OVARIAN CYST DRAINAGE WITH ELECTROCAUTERY AND EXCISION OF RIGHT PARATUBAL CYST. ON (B)(6) 2011, READMITTED FOR ABDOMINAL PAIN. CT NOTED FREE AIR IN ABDOMEN BUT NO EVIDENCE OF BOWEL PERFORATION. WITH IV AND ANTIBIOTICS. REPEAT CT SHOWED IMPROVEMENT OF FREE AIR IN ABDOMEN. DISCHARGED HOME ON (B)(6) 2011. THE PATIENT WAS IN AND OUT OF THE HOSPITAL OVER 6 MONTH PERIOD WITH SYMPTOMS OF RECURRENT SMALL BOWEL OBSTRUCTIONS WHICH ALWAYS IMPROVED WITH HOSPITALIZATION, IV FLUIDS AND ANTIBIOTICS. HAS SYMPTOMS OF PAIN, VOMITING, DISTENTION. TAKING ANTI EMETICS. ON (B)(6) 2011 - ADMITTED AGAIN FOR CONTINUED BOWEL AND ABDOMINAL PAIN. ON (B)(6) 2012 - ADMISSION AND CT AGAIN NOTED FREE AIR IN ABDOMEN. ON (B)(6) 2012, SURGERY CONSULT OBTAINED, SUGGESTS SYMPTOMS MORE INDICATIVE OF CHRONIC CONSTIPATION. NO EVIDENCE OF TRUE SMALL BOWEL OBSTRUCTION." } ], "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": "" } ] }