{ "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": "2955842-2013-00150", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130111", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20121213", "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": "20130114", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "17733", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130111", "brand_name": "DA VINCI S 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": "IS2000 A5.1P7", "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" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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": "20130111", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20121213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2912030", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121213", "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": "3124473", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF GENERAL SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI S SURGICAL SYSTEM, THE SURGEON WAS CONCERNED THAT HE MAY HAVE HIT THE PATIENT'S BOWEL." }, { "mdr_text_key": "10428426", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4) 2013, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE WHO WAS PRESENT DURING THE PLANNED SURGICAL PROCEDURE. THE CSR INDICATED THAT THE SURGEON UTILIZED TRADITIONAL LAPAROSCOPIC INSTRUMENTATION TO PERFORM DISSECTION DURING THE INITIAL PORTION OF THE SURGICAL PROCEDURE AND THAT THE DA VINCI S SURGICAL PROCEDURE WAS UTILIZED TO COMPLETE THE SURGICAL PROCEDURE. THE CSR INDICATED THAT SHE OBSERVED THAT AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE SYSTEM WAS UNDOCKED AND MOVED AWAY FROM THE PATIENT AND SHE OBSERVED THAT THE SURGEON WAS PERFORMING AN INSPECTING THE SURGICAL AREA. THE CSR DISCUSSED THE ISSUE WITH THE PROCTOR, AND THE PROCTOR INDICATED TO HER THAT THE SURGEON MAY HAVE HIT THE PATIENT'S BOWEL AND THAT IF A BOWEL INJURY HAD OCCURRED; IT WAS LIKELY INTRODUCED PRIOR TO USE OF THE DA VINCI SURGICAL SYSTEM. THE CSR INDICATED THAT SHE WAS PRESENT DURING THE ENTIRE SURGICAL PROCEDURE AND SHE DID NOT OBSERVE ANY MALFUNCTION OF THE SITE'S DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS INDETERMINABLE AS TO HOW DAMAGE WAS INTRODUCED TO THE PATIENT'S BOWEL. ISI HAS CONTACTED THE SITE TO OBTAINED ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED." } ], "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": "" } ] }