{ "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": "2955842-2022-13345", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220805", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20220605", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220805", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2518630", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220805", "brand_name": "DA VINCI XI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220805", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20220705", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15173528", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220705", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "297314478", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ALLEGED INTRA-OPERATIVE COMPLICATION OF ¿PERFORATION OF THE SIGMOID COLON¿ THAT THE PATIENT EXPERIENCED CANNOT BE DETERMINED OR IS UNKNOWN DUE TO INSUFFICIENT INFORMATION PROVIDED. ALTHOUGH THE REPORT INDICATED THAT AN INJURY HAD OCCURRED AND IT WAS NOTED THAT, \"A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR,\" DETAILS RELATED TO ANY MEDICAL OR SURGICAL INTERVENTION REQUIRED TO ADDRESS THE ALLEGED TISSUE PERFORATION ARE UNKNOWN. IN THIS CASE, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM AND/OR INSTRUMENT WAS INVOLVED IN THE REPORTED EVENT. FURTHERMORE, THERE WAS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE THAT AN ISI PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE USER REPORT. SYSTEM AND INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED AS THERE WAS LACK OF PRODUCT AND PROCEDURE INFORMATION. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED ¿PERFORATION OF THE SIGMOID COLON¿. THIS INFORMATION WAS RECEIVED FROM A USER MEDWATCH REPORT WITH NO OTHER EVENT/PATIENT INFORMATION PROVIDED. THE ROOT CAUSE OF THE REPORTED ADVERSE EVENT REMAINS UNKNOWN. THERE WAS NO PRODUCT RECEIVED FOR EVALUATION AND NO CONFIRMATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IN SECTION D4 IS NOT APPLICABLE. FIELD D6 IS NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H4 IS BLANK BECAUSE INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE." }, { "mdr_text_key": "297314479", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF AN INTRA-OPERATIVE COMPLICATION, WHICH WAS RECEIVED VIA A USER MEDWATCH REPORT #MW5110571. WITHIN THE USER MEDWATCH REPORT, IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, WHICH ALLEGEDLY THE SURGEON USED TO TAKE DOWN THE ADHESIONS, AND ¿AFTER THAT OCCURRED, THE ARMS EXPERIENCED AN ISSUE¿. THE SURGEON DESCRIBED IT ¿AS THE LEFT HAND WAS MOVED WITH THE VESSEL SEAL DEVICE, THE ROBOTIC ARM MOVED ERRATICALLY¿ AND IMMEDIATELY THE SURGEON NOTED ¿A THROUGH AND THROUGH PERFORATION OF THE SIGMOID COLON¿. THE INSTRUMENT WAS LEFT IN PLACE AND A GENERAL SURGERY CONSULT WAS COMPLETED IMMEDIATELY FOR REPAIR. OTHER INFORMATION RECEIVED FROM THE USER REPORT FURTHER INDICATED THAT ¿AFTER DISCUSSING WITH THE TEAM, WE BELIEVE THAT THE ROBOTIC ARM DRAPE WAS FAULTY¿. ISI IS NOT ABLE TO CONDUCT FOLLOW-UP INVESTIGATION WITH THE USER FACILITY/SURGEON REGARDING THE REPORTED ISSUE DUE TO THE LACK OF FACILITY/SURGEON¿S NAME, ADDRESS AND PHONE NUMBER, ETC. ADDITIONALLY, ISI IS UNABLE TO CONDUCT THE SYSTEM OR INSTRUMENT LOG REVIEW DUE TO LACK OF SYSTEM/INSTRUMENT DETAIL (I.E. SYSTEM SERIAL #, SURGEON NAME, TYPE OF PROCEDURE, ETC.). AT THIS TIME, IT WAS UNCONFIRMED AS TO WHETHER A DA VINCI SURGICAL SYSTEM WAS INVOLVED IN THE REPORTED EVENT AND THERE WAS NO KNOWN ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT. MOREOVER, THERE IS INSUFFICIENT INFORMATION PROVIDED TO DETERMINE IF AN ISI PRODUCT CAUSED OR CONTRIBUTED TO THE OPERATIVE COMPLICATION REFERENCED IN THE USER MEDWATCH REPORT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }