{ "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": "2955842-2013-03253", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130828", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130718", "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 representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "423197", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130828", "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 A6.0P8", "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": "MI", "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": "20130828", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20130730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3314520", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130730", "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": "3838016", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT RETURNED TO THE HOSPITAL SEVERAL DAYS POSTOP COMPLAINING OF ABDOMINAL PAIN. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND A SMALL LACERATION WAS FOUND ON THE PATIENT'S SIGMOID COLON. THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) ASSIGNED TO THE SITE CONTACTED THE SURGEON DIRECTLY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR INDICATED THAT THE SURGEON INFORMED HIM THAT THE ANATOMY WAS VERY DISTORTED DUE TO DISEASE AND THE SURGICAL PROCEDURE WAS AN EXTREMELY TOUGH CASE." }, { "mdr_text_key": "10921706", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI SI HYSTERECTOMY PROCEDURE. THE INITIAL REPORTER ALSO INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S INJURY. THE INITIAL REPORTER DID NOT KNOW THE PATIENT'S CURRENT STATUS. HOWEVER, SHE STATED THAT THE PATIENT'S BOWEL INJURY WAS REPAIRED BY ANOTHER SURGEON ON AN UNKNOWN DATE. ON (B)(4) 2013, ISI ALSO CONTACTED THE CSR ASSIGNED TO THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THE SURGEON INFORMED HIM THAT HE USED A PK DISSECTING FORCEPS INSTRUMENT DURING THE SURGICAL PROCEDURE TO MOVE THE PATIENT'S SIGMOID COLON OUT OF THE WAY SO THAT HE COULD HAVE A BETTER VIEW OF THE PATIENT'S ANATOMY. THE CSR STATED THAT THERE WAS NO ALLEGATION THAT THE PK DISSECTING FORCEPS INSTRUMENT MALFUNCTIONED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE SURGEON AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE A LACERATION TO THE SIGMOID COLON AFTER UNDERGOING A DA VINCI SI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNCLEAR HOW THE PATIENT'S INJURY 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": "" } ] }