{ "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": "2955842-2016-00747", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20161020", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160912", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20161020", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "695867", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20161020", "brand_name": "DA VINCI SI 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": "IS3000 A60P9B", "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": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250826", "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": "20161020", "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": "20160923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6044831", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160923", "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": "57977916", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. 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: AFTER UNDERGOING A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL PIN POINT HOLE IN THE BOWEL AND UNDERWENT AN EXPLORATORY LAPAROTOMY TO REPAIR THE HOLE IN THE BOWEL. FURTHERMORE, THE ROOT CAUSE OF THE SMALL HOLE IN THE BOWEL IS UNKNOWN." }, { "mdr_text_key": "57977917", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY A FEW DAYS AFTER COMPLETION OF A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, A SMALL HOLE THAT WAS DESCRIBED AS BEING PIN POINT IN SIZE WAS FOUND IN THE BOWEL. AS A RESULT THE PATIENT CAME BACK WITH UNSPECIFIED SIGNS OF INFECTION AND UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE IN THE BOWEL. ON 09/30/2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE CSR STATED THAT HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT THE PROCEDURE WAS NOT RECORDED. APPROXIMATELY A FEW DAYS AFTER THE PROCEDURE THE CSR BELIEVES THE PATIENT CAME BACK TO THE HOSPITAL WITH SIGNS OF INFECTION. TO HIS KNOWLEDGE, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE ON AN UNSPECIFIED DATE TO REPAIR THE HOLE. THE CSR MENTIONED THAT OTHER LAPAROSCOPIC INSTRUMENTS WERE USED DURING THE INITIAL CHOLECYSTECTOMY SURGICAL PROCEDURE. WHEN THE CSR FOLLOWED UP WITH THE SURGEON, THE SURGEON STATED ROBOTICALLY THE SURGERY WENT VERY WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE CSR, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS ALSO NO ALLEGATION DURING THE SURGICAL PROCEDURE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES OCCURRED." } ], "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": "" } ] }