{ "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": "2955842-2014-05312", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20140828", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20070430", "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": "20140829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "525370", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140828", "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": "IS1200 A4.3P8", "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": [ "Device Operates Differently Than Expected", "Torn Material" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20140828", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20140803", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4045623", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140421", "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": "12185791", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. NO SYSTEM LOGS ARE AVAILABLE FOR REVIEW REGARDING THE REPORTED DA VINCI SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED INTRA-OPERATIVE COMPLICATIONS WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS IS UNKNOWN. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "4907075", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED ROBOTIC RADICAL PROSTATECTOMY PROCEDURE FOR PROSTATE CANCER ON (B)(6) 2007. ACCORDING TO THE OPERATIVE REPORT, A ROBOTIC MALFUNCTION OCCURRED DURING THE POSTERIOR BLADDER NECK DISSECTION CAUSING THE SYSTEM TO REQUIRE REBOOTING ABOUT 20 TIMES. THE SURGEON INDICATED, IT WOULD TAKE APPROXIMATELY 30-45 SECONDS TO REBOOT THE ROBOT AFTER EACH ONE OF THE MANUAL FAULT OVERRIDES. THERE WERE ALSO TIMES WHERE THE ROBOT WOULD ACTUALLY TAKE 5 MINUTES TO REBOOT AND WE WOULD HAVE TO GET THE REPRESENTATIVE ON THE TELEPHONE TO DO THIS. DURING BLADDER NECK RECONSTRUCTION, THE SURGEON INDICATED, DUE TO THE ROBOT MALFUNCTION, SOME OF THESE SUTURES TORE THROUGH THE POSTERIOR BLADDER NECK. THE SURGEON ENDED UP PERFORMING ANOTHER FIGURE-OF-EIGHT SUTURE TO RECONSTRUCT THE BLADDER NECK A LITTLE BIT FURTHER. IN THE OPERATIVE REPORT, A RECTO-SIGMOID LACERATION WAS ALSO DISCOVERED AND REPAIRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. THERE WERE NO REPORTED SEQUELAE. ON 08/28/2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE INCIDENT REPORT FOR THE REPORTED DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INCIDENT REPORT, AN EVENT OCCURRED BUT THERE WAS NO HARM AND NO TREATMENT WAS REQUIRED. THE INCIDENT REPORT ALSO INDICATED THAT THERE WAS AN INTERNAL PROBLEM IN THE RIGHT ARM BUT THE SURGEON WAS ABLE TO FINISH THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE RISK MANAGER." } ], "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": "" } ] }