{ "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": "2955842-2010-00238", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20100604", "manufacturer_address_2": "", "pma_pmn_number": "K080207", "date_of_event": "20100302", "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": [ "Other", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20100611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20100604", "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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20100604", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS", " ESU", " ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "46 YR", "patient_sex": "", "patient_weight": "61", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Laceration(s)", "Injury" ] } ], "distributor_city": "", "date_report": "20130117", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1715883", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130117", "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": "8627083", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN ADDITIONAL INVESTIGATION WITH THE SITE'S RISK MANAGEMENT DEPARTMENT WAS PERFORMED. IT WAS REPORTED THAT THE DAMAGE TO THE PT'S URETER WAS UNRELATED TO THE DA VINCI S SYSTEM AS THERE WAS NO MALFUNCTION OF THE SYSTEM DURING THE SURGICAL PROCEDURE. THEY ALSO ADVISED THAT THEY WOULD BE UNABLE TO PROVIDE THE SURGEON'S OPINION AS TO THE CAUSE OF THE PT INJURY DUE TO PEER REVIEW PROTECTION." }, { "mdr_text_key": "1617234", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON MAY 4, 2010, A WALL STREET JOURNAL (WSJ) ARTICLE TITLED \"SURGICAL ROBOT EXAMINED IN INJURIES\" WAS PUBLISHED. THE ARTICLE INCLUDED DETAILS CONCERNING PT INJURIES AND A PT DEATH AT (B) (6) HOSPITAL. NONE OF THE ALLEGATIONS OF PT INJURIES IN THE WSJ ARTICLE WERE REPORTED TO ISI, HOWEVER, ON (B) (6) 2010, UPON FOLLOW UP WITH THE HOSPITAL, (B) (6), THE VP OF COMMUNITY RELATIONS, CONFIRMED ONE PT INJURY. REPORTEDLY, AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT DID NOT HAVE URINE OUTPUT. ON (B) (6) 2009, A CYSTOSCOPY WITH URETEROSCOPY AND EXPLORATORY LAPAROSCOPY PROCEDURE WAS PERFORMED WHICH REVEALED THAT THE PT HAD BILATERAL URETERAL TRANSECTION. BILATERAL URETERAL REIMPLANTATIONS AND A BILATERAL URETERAL STENT PLACEMENT WAS REQUIRED TO REPAIR THE AFFECTED AREA. IN ADDITION, (B) (6) STATED THAT (B) (6) HAS NO RECORD OF THE OTHER PT INJURIES/PT DEATH RELATED TO THE DA VINCI S SURGICAL SYSTEM AS INDICATED IN THE WSJ ARTICLE. DAMAGE TO THE PT'S URETER PROLONGED THE PT'S HOSPITALIZATION AND THE PT HAS RETURNED TO THE HOSPITAL DUE TO POST OPERATIVE COMPLICATIONS. THE HOSPITAL WAS UNABLE TO PROVIDE ADDITIONAL INFO CONCERNING THE PT'S STATUS." }, { "mdr_text_key": "10539232", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, AN ARTICLE WAS PUBLISHED ON THE INTERNET BY CITRON RESEARCH TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR THE DEVIL IN DISGUISE. THE ARTICLE ALLEGED THAT THE PATIENT SUED DOUGLAS WENTWORTH HOSPITAL IN NEW HAMPSHIRE DUE TO BOTH OF THE PATIENT'S URETERS WERE SEVERED DURING A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2009. THE ARTICLE ALSO ALLEGED THAT THE LAWSUIT FILED BY THE PATIENT ALLEGES THAT HER INJURIES RESULTED FROM THE SURGEON'S LACK OF TRAINING ON THE DA VINCI SURGICAL SYSTEM. ISI'S INVESTIGATION INTO THE ALLEGATIONS REFERENCED IN THE CITRON PUBLISHED BY CITRON FOUND THAT ISI WAS NOT NAMED AS A DEFENDANT IN THE PATIENT'S LAWSUIT. HOWEVER, THE PATIENT'S LAWSUIT ALLEGED THAT AT THE TIME OF HER SURGICAL PROCEDURE, THE SURGEONS WHO PERFORMED HER DA VINCI HYSTERECTOMY PROCEDURE WHERE NOT QUALIFIED OR COMPETENT TO USE THE DA VINCI SURGICAL SYSTEM. THE LAWSUIT ALLEGED THAT USE OF THE DA VINCI SURGICAL SYSTEM REQUIRED EXTENSIVE TRAINING AND EXPERIENCE IN ORDER TO BECOME COMPETENT IN THE USE OF THE DEVICE, BUT THAT CATASTROPHIC INJURIES COULD (AND DID) OCCUR TO THE PATIENT IF THE SURGEON WAS NOT PROPERLY SKILLED. THESE ALLEGATIONS WERE NOT PREVIOUSLY REPORTED TO INTUITIVE SURGICAL AND HAVE NOT BEEN SUBSTANTIATED. ANY FURTHER INFORMATION RECEIVED BY THE COMPANY WILL BE PROVIDED VIA A FOLLOW UP MDR." } ], "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": "02/16/2013" } ] }