{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2024-17840", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20240807", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240203", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "TW", "manufacturer_contact_area_code": "408", "date_added": "20240807", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "552358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240807", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/25/2024;11/29/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250821", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20240807", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "49 YR", "patient_sex": "Male", "patient_weight": "59 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Abdominal Pain", "Diarrhea", "Vomiting", "Stenosis", "Abdominal Pain", "Diarrhea", "Vomiting", "Stenosis" ] } ], "distributor_city": "", "date_report": "20240715", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19929722", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240715", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "348702330", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT." }, { "mdr_text_key": "348702331", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION WHICH A TEMPORARY ILEOSTOMY WAS PLACED IN THE LOWER RIGHT ABDOMEN. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DA VINCI DEVICE MALFUNCTIONS OR ANY COMPLICATIONS. NO SIGNS OR SYMPTOMS OF BOWEL OBSTRUCTIONS HAVE BEEN REPORTED. THE PATIENT WAS FOUND WITH NARROWING OF THE ANUS THREE MONTHS LATER, AND AN OUTPATIENT PROCEDURE WAS PERFORMED. TWO MONTHS LATER, THE PATIENT WAS SCHEDULED FOR AN ILEOSTOMY TAKEDOWN BUT WAS FOUND WITH ANASTOMOSIS SITE NARROWING FROM THE PRE-PROCEDURAL COLOSCOPY. A SPHINCTEROTOMY WAS PERFORMED FOR THE ANAL STENOSIS ON AND THE PATIENT HAS BEEN REPORTED AS DOING WELL POST-PROCEDURALLY. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DA VINCI DEVICES NOR THE PROCEDURE." }, { "mdr_text_key": "352643071", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "352643072", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION OBTAINED AS THE FOLLOWS: THE PATIENT EXPERIENCED ABDOMINAL BLOATING AND DISCOMFORT SIX MONTHS AFTER THE PROCEDURE. THERE WERE TYMPANIC SOUNDS DURING PHYSICAL EXAMINATION, AND A SEGMENT OF THE SMALL INTESTINE WAS FOUND TO BE BLOATED BUT STILL PASSABLE. THE BLOATING WAS FOUND TO BE DUE TO A SMALLER ANAL OPENING, WHICH REQUIRED A PROCEDURE TO DILATE THE ANUS. THE PATIENT UNDERWENT A PROCEDURE THREE DAYS LATER FOR THE ANAL STENOSIS, AND WAS DISCHARGED SEVEN DAYS AFTER THE PROCEDURE WITH NORMAL BOWEL MOVEMENT AND WITH SIGNIFICANT RELIEF FROM ABDOMINAL BLOATING. THE STUDY INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DA VINCI DEVICES NOR THE PROCEDURE." }, { "mdr_text_key": "361385250", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AFTER CONTINUED COMPLICATIONS OF DIARRHEA, CONSTIPATION, ABDOMINAL PAIN, AND CRAMPS, THE PATIENT AGREED TO A PERMANENT STOMA AND WAS ADMITTED FOR SURGERY. AFTER PERMANENT STOMA SURGERY, THE PATIENT WAS STARTED ON A CLEAR LIQUID DIET THEN TRANSITIONED TO A SOFT DIET WITH NO VOMITING AFTER EATING. THE PATIENT'S POST-OPERATIVE RECOVERY WAS GOOD, AND HE WAS DISCHARGED." }, { "mdr_text_key": "361385251", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/20/2024;12/23/2024" } ] }