{ "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": "2955842-2016-00378", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20160526", "manufacturer_address_2": "", "pma_pmn_number": "K063221", "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": "", "manufacturer_contact_area_code": "", "date_added": "20160526", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "335868", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160526", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "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": "20160526", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "76 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available", "No Code Available" ] } ], "distributor_city": "", "date_report": "20160426", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5682286", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160426", "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": "46086264", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THE DATE THE PATIENT UNDERWENT THE DA VINCI-ASSISTED SURGICAL PROCEDURE IS UNKNOWN. IN ADDITION, IT IS UNKNOWN WHY THE PATIENT REQUIRED A COLOSTOMY, WHAT TYPE OF SEVEN-HOUR OPERATION THE PATIENT UNDERWENT, WHAT DATE HE UNDERWENT THE SEVEN-HOUR SURGICAL PROCEDURE, AND WHY THE OPERATION WAS PERFORMED. ON 05/23/2016, ISI CONTACTED THE AUTHOR OF THE ARTICLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, THE AUTHOR INDICATED THAT SHE HAD NO FURTHER INFORMATION TO PROVIDE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE PATIENT'S DA VINCI-ASSISTED ABDOMINAL SURGERY. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE ARTICLE, THE PATIENT REQUIRED A COLOSTOMY AFTER UNDERGOING AN UNSPECIFIED DA VINCI-ASSISTED ABDOMINAL SURGICAL PROCEDURE. HOWEVER, THE REASON AS TO WHY THE PATIENT REQUIRED THE COLOSTOMY IS UNKNOWN. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS." }, { "mdr_text_key": "46086405", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 04/26/2016, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF THE (B)(6) ARTICLE TITLED, DO YOU NEED COMPLEX SURGERY? SOME DOCTORS MAY NOT HAVE MUCH PRACTICE (2016). ACCORDING TO THE ARTICLE, A (B)(6) MALE PATIENT CHOSE TO UNDERGO ELECTIVE ABDOMINAL SURGERY IN HIS HOME TOWN OF (B)(6), AFTER ROBOTIC PROSTATE SURGERY AT A LARGER HOSPITAL IN (B)(6) NEARLY KILLED HIM AND LEFT HIM WITH A COLOSTOMY. THE PATIENT REPORTEDLY WANTED TO BE BACK IN HIS TOWN AND HAD CONFIDENCE IN HIS SURGEON. THE PATIENT UNDERWENT A SEVEN-HOUR OPERATION THAT WENT WELL AT A SPECIFIED HOSPITAL. THE ARTICLE INDICATED THAT THE PATIENT RECENTLY SAID HE IS ALMOST BACK TO NORMAL." } ], "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": "" } ] }