{ "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": "2955842-2013-00309", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130129", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120402", "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": "20130129", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "39479", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130129", "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 A60P6", "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": "AR", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20130129", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Numbness" ] } ], "distributor_city": "", "date_report": "20121231", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2933637", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121231", "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": "22040469", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2012, A PATIENT POSTED THE FOLLOWING INFORMATION ON ISI'S SOCIAL NETWORK SITE VIA (B)(6): \"I HAD THE DAVINCI SURGERY 8 MONTHS AGO. I STILL HAVE SOME NUMBNESS IN ONE AREA AND I STILL HAVE SOME PAIN. DO YOU KNOW WHY I WOULD STILL HAVE PAIN AFTER THIS LONG? I WILL BE SEEING MY DOCTOR ON (B)(6). I HAVE ASKED HER BEFORE WHY IT STILL HURT; SHE TOLD ME SINCE I HAD PROBLEMS WITH MY LEFT SIDE BEFORE MY SURGERY THAT IS WHY IT STILL HURTS. IT DOES NOT MAKE SENSE AT ALL TO ME. AND ALSO ABOUT A WEEK AGO I STARTED TO SPOT. IT LASTED FOR A DAY AND A HALF.\"" }, { "mdr_text_key": "22202580", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS CONTACTED THE OPERATING SURGEON AT THIS FACILITY, AND SHE INDICATED THAT SHE DOES NOT RECALL ANY MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRING DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT WAS POSITIONED IN THE TRENDELENBURG POSITION. THE SURGEON ALSO INDICATED THAT SHE HAS NOT RECEIVED ANY REPORT THAT THE PATIENT EXPERIENCED ANY POST SURGICAL COMPLICATIONS DESPITE THE PATIENT'S REPORT THAT SHE WAS IN THE HOSPITAL FOR A WEEK. THE DOCTOR ALSO STATED THAT SHE IS UNABLE TO PROVIDE ANY OTHER DETAILS CONCERNING THE PATIENT WITHOUT WRITTEN CONSENT FROM THE PATIENT. FURTHERMORE, ON (B)(6) 2013, THE PATIENT WAS CONTACTED AND PROVIDED MORE INSIGHT ON THE REPORTED COMPLAINT. IT WAS STATED THAT PRIOR TO HAVING THE SCHEDULED HYSTERECTOMY PROCEDURE, SHE EXPERIENCED HEAVY MENSTRUAL CYCLES. AT THE PRESENT TIME, SHE FEELS NUMBNESS ON HER LEFT SIDE WHERE THE SURGICAL INCISION WAS. DURING HER LAST VISIT WITH THE SURGEON, IT WAS STATED THAT IT COULD BE AN INFECTION OR IT COULD BE THE PATIENT'S BOWELS. THE PATIENT THEN WENT TO HER PRIMARY CARE PHYSICIAN (PCP), WHO PERFORMED AN ULTRASOUND. THE ULTRASOUND RESULTS CAME BACK FINE. THE PCP PRESCRIBED SOME PAIN MEDICATION AND RECOMMENDED MORE FIBER IN HER DIET. NO FURTHER INFORMATION WAS PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "" } ] }