{ "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": "2955842-2010-00270", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100618", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NOT APPLICABLE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20100710", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100618", "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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "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": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20100618", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS", " ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Neuropathy" ] } ], "distributor_city": "", "date_report": "20100521", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1735761", "removal_correction_number": "", "number_devices_in_event": "", "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": "8559600", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON JUNE 23, 2010, AND JULY 2, 2010, ADDITIONAL INFORMATION WAS PROVIDED BY DR. (B) (6), THE CONSOLE SURGEON WHO PERFORMED THE DA SI HYSTERECTOMY PROCEDURE WHEN THE EVENT OCCURRED. THE PATIENT WAS PROPERLY POSITIONED IN DEEP TRENDELENBURG, WITH THICK PADDING UNDER THE PATIENT'S BODY AND BUTTOCKS. THE PROCEDURE WAS PROLONGED AS IT WAS DR. (B) (6) FIRST HYSTERECTOMY PROCEDURE USING THE SYSTEM AND THE UTERINE MANIPULATOR WAS INEFFECTIVE. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND FROM DR. (B) (6) POINT OF VIEW, THE PATIENT RECOVERED SEAMLESSLY FROM THE CASE. POST-OPERATIVELY, THE PATIENT INITIALLY COMPLAINED OF NOT BEING ABLE TO BEAR WEIGHT ON HER LEFT LOWER EXTREMITY. A NEUROLOGY IN-HOSPITAL CONSULTATION WAS ORDERED AND THE PATIENT RECOVERED HER ABILITY TO WALK WITHIN HOURS AFTER THE CONSULTATION. ONE WEEK LATER, THE PATIENT COMPLAINED OF ONE EPISODE OF PAIN, WHICH INCREASED IN INTENSITY OVER THE NEXT WEEK. THE PATIENT SAW THE SAME NEUROLOGIST AS AN OUTPATIENT AND BEGAN TAKING NEUROTIN. THE PATIENT REQUESTED A SECOND OPINION, WHICH WAS IMMEDIATELY ORDERED AND THE PATIENT HAD A SECOND OPINION FOUR DAYS LATER. AN MRI AND EMG WERE ORDERED AND BOTH WERE NEGATIVE. THE PATIENT WAS REFERRED TO A SPECIALIST WHO DIAGNOSED THE PATIENT'S SYMPTOMS AS SUPERFICIAL NERVE NEUROPATHY AND INCREASED THE PATIENT'S NEURONTIN DOSE. THE PATIENT RETURNED TO WORK TEN WEEKS POST-OP." }, { "mdr_text_key": "8618963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON JUNE 8, 2010, AN EMAIL WAS SENT TO THE CONSOLE SURGEON REQUESTING ADDITIONAL INFO REGARDING THE EVENT. ON JUNE 14, 2010, A FOLLOW-UP EMAIL WAS SENT TO THE CONSOLE SURGEON. ON JUNE 17, 2010, A VOICE MESSAGE WAS LEFT FOR THE HOSPITAL'S DIRECTOR OF PT SERVICES REQUESTING ADDITIONAL INFO REGARDING THE EVENT. AS OF JUNE 18, 2010, NO RESPONSE HAS BEEN RECEIVED FROM THE CONSOLE SURGEON NOR THE HOSPITAL'S DIRECTOR OF PT SERVICES. SINCE NO DEVICES HAVE BEEN RETURNED FOR EVAL AND NO ADDITIONAL INFO HAS BEEN RECEIVED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFO IS RECEIVED." }, { "mdr_text_key": "1615025", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS PERFORMED ON (B) (6), 2010, THE PT CLAIMED TO HAVE NEUROPATHY. NO SYSTEM MALFUNCTION OCCURRED AND THE PLANNED PROCEDURE WAS SUCCESSFULLY COMPLETED." }, { "mdr_text_key": "1408544", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN UNSTABLE DEUCE KNEE APPROXIMATELY 18 MONTHS AFTER IMPLANTATION. THE SURGEON DOES NOT FAULT THE DEVICE." } ], "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": "07/10/2010" } ] }