{ "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": "2955842-2016-00615", "type_of_report": [ "Initial submission" ], "product_problem_flag": "", "date_received": "20160819", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20160629", "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": "", "manufacturer_contact_area_code": "", "date_added": "20160819", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "543331", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160819", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20160819", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Complaint, Ill-Defined", "Injury", "Burn, Thermal", "Abdominal Distention", "Bowel Perforation", "Fistula", "Complaint, Ill-Defined", "Injury", "Burn, Thermal", "Abdominal Distention", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20160721", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5889113", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160721", "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": "52547573", "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 OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE ON (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, ALL 4 ROBOTIC INSTRUMENT USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE HAVE BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES WITH NO REPORTED ISSUES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A PERFORATED BOWEL AND A RECTAL FISTULA. HOWEVER, AT THIS TIME, THE ROOT CAUSES THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN." }, { "mdr_text_key": "52547574", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI - ASSISTED HYSTERECTOMY WITH PARA-AORTIC LYMPH NODE DISSECTION PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE INITIAL REPORTER, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR), THE SURGEON INFORMED HER THAT THE DA VINCI - ASSISTED SURGICAL PROCEDURE WAS SMOOTH AND STRAIGHTFORWARD. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY 1, THE PATIENT'S STOMACH WAS NOTED TO BE DISTENDED AND THE PATIENT DID NOT SEEM TO BE WELL. ON POST-OPERATIVE DAY 2, A CT-SCAN WAS PERFORMED ON THE PATIENT AND WAS FOUND TO BE NEGATIVE. ON POST-OPERATIVE DAY 3, ANOTHER CT-SCAN WAS PERFORMED AND A PERFORATION OF THE DUODENUM WAS IDENTIFIED. ON POST-OPERATIVE DAY 6, THE PATIENT UNDERWENT OPEN SURGERY TO REPAIR A 5 MM PERFORATION OF THE DUODENUM. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT THE BOWEL PERFORATION WAS SURROUNDED BY WHITISH TISSUE MEASURING 1 CM X 1 CM. ACCORDING TO THE CSR, THE SITE BELIEVES THE WHITISH TISSUE AND PERFORATION WERE CAUSED BY A THERMAL INJURY. HOWEVER, THE SURGEON WAS REPORTEDLY UNABLE TO EXPLAIN HOW THE THERMAL INJURY MIGHT HAVE OCCURRED. IN ADDITION, ON AN UNSPECIFIED DATE POST-OPERATIVELY, A RECTAL FISTULA WAS ALSO FOUND. THE PATIENT UNDERWENT ANOTHER UNSPECIFIED PROCEDURE ON AN UNSPECIFIED DATE TO TREAT THE RECTAL FISTULA. HOWEVER, THE SURGEON INDICATED THAT NO REPAIR WAS ACTUALLY PERFORMED FOR THE RECTAL FISTULA. PER THE CSR, THE SITE BELIEVES THAT THE PATIENT'S RECTUM WAS ALSO LIKELY INJURED AT SOME POINT DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THE CSR INDICATED THAT THE ONLY 2 NON-ROBOTIC INSTRUMENTS USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE WERE A BOWEL GRASPER AND A SUCTION IRRIGATOR. THE SURGEON USED THE FOLLOWING INSTRUMENTS DURING THE SURGICAL PROCEDURE: A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT IN ARM 1 OF THE PATIENT SIDE CART (PSC), FENESTRATED BIPOLAR FORCEPS INSTRUMENT IN ARM 2, AND A PROGRASP FORCEPS INSTRUMENT IN ARM 3. THE SURGEON ALSO INDICATED THAT SHE ONLY USED THE PROGRASP FORCEPS INSTRUMENT TO LIFT THE BOWEL. SHE REPORTEDLY DID NOT GRASP THE PATIENT'S BOWEL WITH THE INSTRUMENT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED." } ], "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": "" } ] }