{ "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": "I", "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": "2955842-2016-00821", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20161117", "manufacturer_address_2": "", "pma_pmn_number": "", "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": [ "COMPANY REPRESENTATIVE", "LITERA" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161117", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "759979", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161117", "brand_name": "DA VINCI 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": "", "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", "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": "20250725", "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": "20161117", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Bowel Perforation", "Injury", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20161018", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6111190", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161018", "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": "60281796", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENTS. THE FOLLOWING INFORMATION IS UNKNOWN: THE HOSPITAL NAME(S) WHERE THE DA VINCI-ASSISTED SURGICAL PROCEDURES WERE PERFORMED, WHAT DATE(S) THE SURGICAL PROCEDURES WERE PERFORMED, WHAT SPECIFIC DEVICE MALFUNCTIONS OCCURRED, AND THE OUTCOMES OF THE SURGICAL PROCEDURES. ISI HAS ATTEMPTED TO CONTACT THE ARTICLE'S CORRESPONDING AUTHOR TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE MALFUNCTIONS AND OPERATIVE COMPLICATIONS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE JOURNAL ARTICLE, A NUMBER OF PATIENTS ALLEGEDLY EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNSPECIFIED DEVICE MALFUNCTIONS THAT OCCURRED DURING ROBOTIC SURGERIES. THERE IS INSUFFICIENT INFORMATION PROVIDED WITHIN THE JOURNAL ARTICLE TO DETERMINE SPECIFIC DETAILS OF THE DEVICE MALFUNCTIONS." }, { "mdr_text_key": "60281797", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 10/18/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE OPEN MEDICINE JOURNAL ARTICLE TITLED, MALFUNCTIONS OF ROBOTIC SYSTEM IN SURGERY: ROLE AND RESPONSIBILITY OF SURGEON IN LEGAL POINT OF VIEW (FERRARESE, ET AL., 2016). THE PURPOSE OF THE JOURNAL ARTICLE WAS TO ESTIMATE THE IMPACT OF DEVICE MALFUNCTIONS IN ROBOTIC SURGERY AND ITS CONSEQUENT LEGAL IMPLICATIONS. WITHIN THE ARTICLE, THE FOLLOWING IS STATED: FROM A RS MALFUNCTION, 16 CAUSED PATIENT DAMAGE, OF WHICH 13 WERE MILD AND RESOLVED WITHOUT SEQUELAE, AND 3 WERE COMPLEX, INCLUDING AN EXTERNAL ILIAC VEIN LESION, ILEAL PERFORATION, AND URETHRAL LESION. THE LATTER WERE TREATED INTRA-OPERATIVELY WITH DIRECT ILIAC VEIN AND ILEAL SUTURE AND REIMPLANTATION OF THE URETHRAL LESION. NO FURTHER INFORMATION WAS PROVIDED WITHIN THE ARTICLE REGARDING THE OPERATIVE COMPLICATIONS." } ], "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": "" } ] }