{ "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": "2955842-2013-02803", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130729", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20120918", "reprocessed_and_reused_flag": "", "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": "20130729", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "352840", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130729", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC ELECTROSURGICAL 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": "0", "model_number": "", "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": "CA", "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": "20130729", "sequence_number_treatment": [ "DA VINCI SURG SYS., INSTRUMENTS, ACCESSORIES & ES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Erosion", "Emotional Changes", "Incontinence", "Laceration(s)", "Pain", "Injury", "Burn, Thermal", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130628", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3251003", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130628", "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": "10960251", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED IN THE LEGAL COMPLAINT, INTUITIVE SURGICAL, INC. IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY DURING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "3666494", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2012, SUSTAINED AN INTRA-OPERATIVE THERMAL BURN TO THE BLADDER, RESULTING IN A LACERATION THAT REQUIRED THE PLACEMENT OF A FOLEY CATHETER AND FURTHER HOSPITALIZATION. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT REQUIRED AN INTRA-OPERATIVE PLACEMENT OF A TRANSOBTURATOR TAPE (BLADDER SLING) WHICH CAUSED EROSION OF THE PATIENT'S VAGINAL MESH, REQUIRING THE PATIENT TO UNDERGO TWO SUBSEQUENT SURGICAL PROCEDURES. PER THE INFORMATION INDICATED IN THE LEGAL COMPLAINT, THE PATIENT CONTINUES TO SUFFER FROM CHRONIC VAGINAL PAIN AND INCONTINENCE, THUS REQUIRING THE PATIENT TO WEAR BLADDER PADS. THE PATIENT ALSO REQUIRES FURTHER BLADDER RECONSTRUCTIVE SURGERY AND URETERAL RE-IMPLANTATION. REPORTEDLY DUE TO THE INJURY SUSTAINED BY THE PATIENT DURING THE SURGICAL PROCEDURE, THE PATIENT HAS UNDERGONE AND CONTINUES TO UNDERGO MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS AND PROCEDURES, PHYSICIAN CONSULTATIONS AND ADDITIONAL SURGERIES. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS AND PERMANENT INJURY." } ], "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": "" } ] }