{ "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": "2955842-2013-04143", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131009", "manufacturer_address_2": "", "pma_pmn_number": "K021036", "date_of_event": "20090406", "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": "", "manufacturer_contact_area_code": "", "date_added": "20131009", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "512546", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131009", "brand_name": "DA VINCI 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": "IS1200", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20131009", "sequence_number_treatment": [ "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Information" ] } ], "distributor_city": "", "date_report": "20131101", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3397159", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131101", "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": "19568100", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING A MEDICAL RECORD REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2009. THE OPERATIVE REPORT FOR THE DA VINCI PROSTATECTOMY PROCEDURE WAS NOT PROVIDED; HOWEVER, AN OPERATIVE REPORT FOR THE REPAIR OF ENTEROTOMY AND SMALL BOWEL RESECTION WAS PROVIDED. ACCORDING TO THE PROVIDED OPERATIVE REPORT, THE SURGEON PERFORMING THE DA VINCI PROSTATECTOMY CONSULTED WITH ANOTHER SURGEON DURING THE PROSTATECTOMY DUE TO AN INTRA-OPERATIVE INJURY TO THE PATIENT'S SMALL BOWEL. IT WAS NOTED THAT THE PATIENT SUSTAINED THE SMALL BOWEL INJURY (ENTEROTOMY X2) DUE TO SEVERE ADHESIONS OF THE PELVIS FROM PREVIOUS TRANSABDOMINAL SURGERY. THE PATIENT RECEIVED A SMALL BOWEL RESECTION OF MID TO DISTAL ILEUM, ABOUT A 12 CM SEGMENT, WITH PRIMARY ANASTOMOSIS. THE PATIENT TOLERATED THE SMALL BOWEL REPAIR WELL AND THE REMAINDER OF THE PROSTATECTOMY WAS LEFT UNDER THE CARE OF THE INITIAL DA VINCI SURGEON. THERE WAS NO SPECIFIC ALLEGATION OF ANY MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY IN THE PROVIDED DOCUMENT. NO OTHER INFORMATION WAS PROVIDED. SINCE THE DA VINCI PROSTATECTOMY OPERATIVE REPORT WAS NOT PROVIDED, IT IS UNKNOWN IF THERE WERE ANY OTHER COMPLICATIONS RELATED TO THE PROSTATECTOMY PROCEDURE. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "19758228", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PROVIDED OPERATIVE REPORT DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROSTATECTOMY PROCEDURE." }, { "mdr_text_key": "20422150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, A PERSON FROM THE SITE'S RISK MANAGEMENT CONTACTED INTUITIVE SURGICAL, INC. (ISI). THE CONTACT INDICATED THAT THEY ARE UNABLE TO RELEASE ANY PATIENT INFORMATION AND WILL NOT BE ABLE TO PROVIDE ANY ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT." } ], "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": "11/01/2013" } ] }