{ "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": "2955842-2013-02055", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20130608", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20100801", "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", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130610", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "257086", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130608", "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": "IS3000A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130608", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20130809", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3157108", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130809", "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": "11136356", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) RELATED TO THE REPORTED EVENT." }, { "mdr_text_key": "18074556", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4)." }, { "mdr_text_key": "3484973", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, THE INITIAL REPORTER OF THIS COMPLAINT CONTACTED INTUITIVE SURGICAL INC. (ISI) ALLEGING THAT THE PATIENT WAS INJURED DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED IN (B)(6) 2010 AT (B)(6). ISI CONTACTED THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL PROCEDURE WENT FINE. HOWEVER, THE INITIAL REPORTER CLAIMED THAT AFTER THE PATIENT WENT HOME, SHE EXPERIENCED ACUTE ABDOMINAL PAIN. THE PATIENT WAS SUBSEQUENTLY SEEN AND TREATED BY A PHYSICIAN AT (B)(6) ON AN UNSPECIFIED DATE/TIME. APPROXIMATELY 10 DAYS LATER, A CAT SCAN WAS PERFORMED ON THE PATIENT AND IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED AN INJURY TO HER BOWEL. THE INITIAL REPORTER STATED THAT HE WAS TOLD THAT THE INJURY TO THE BOWEL WAS AN ELECTRICAL BURN. ADDITIONAL SURGERIES TO REPAIR THE PATIENT'S BOWEL WERE PERFORMED. THE INITIAL REPORTER INDICATED THAT THE PATIENT HAD RECOVERED FROM THE SURGERIES. ISI HAS NO PREVIOUS RECORD OF THIS COMPLAINT. IF ADDITIONAL INFORMATION CAN BE OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT." }, { "mdr_text_key": "10802861", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL HAS ATTEMPTED TO CONTACT THE RISK MANAGEMENT DEPARTMENT OF THE MEDICAL CENTER INVOLVED WITH THIS COMPLAINT TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. BASED ON THE INFORMATION, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE INITIAL REPORTER CLAIMED THAT THE PATIENT SUSTAINED A BOWEL INJURY DURING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IT IS ALSO UNKNOWN WHAT CAUSED THE REPORTED INJURY TO THE PATIENT'S BOWEL." } ], "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": "08/30/2013;08/30/2013" } ] }