{ "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": "2955842-2014-03943", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140626", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140505", "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": "20140627", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "375110", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140626", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "AK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20140626", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Bowel Burn", "Pain" ] } ], "distributor_city": "", "date_report": "20140527", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3898271", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140527", "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": "18026697", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI LEFT SALPINGO-OOPHORECTOMY PROCEDURE, THE PATIENT SUSTAINED A BOWEL INJURY THAT THE SURGEON FELT WAS LIKELY DUE TO A THERMAL ISSUE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT THE PATIENT WAS STILL IN THE HOSPITAL, HAD ENDED UP DEVELOPING AN ABSCESS, AND RECEIVED A COLOSTOMY. THE PATIENT'S CONDITION WAS REPORTEDLY IMPROVING. ON (B)(64 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON INVOLVED WITH THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON DESCRIBED THE THERMAL BOWEL INJURY AS BEING 1 CM IN SIZE AND LOCATED IN THE SIGMOID COLON. ACCORDING TO THE SURGEON, NO INAPPROPRIATE CONTACT WITH ENERGIZED INSTRUMENTS WHILE ACTIVATED WAS OBSERVED DURING THE DA VINCI SURGICAL PROCEDURE. IN ADDITION, THE BOWEL INJURY WAS NOT SEEN OR NOTICED INTRA-OPERATIVELY. THE SURGEON DENIED THAT ANY EVIDENCE OF ARCING OF ELECTRICAL ENERGY FROM AN INSTRUMENT WAS OBSERVED DURING THE SURGICAL PROCEDURE. TEN DAYS POST-OPERATIVELY, THE PATIENT WAS READMITTED FOR COMPLAINTS OF PAIN AND A CT-SCAN WAS PERFORMED. THE PATIENT'S BOWEL INJURY WAS SURGICALLY REPAIRED. DETAILS OF THE SURGICAL REPAIR WERE NOT PROVIDED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. AT THIS TIME, THE PATIENT CURRENTLY HAS A TEMPORARY COLOSTOMY. THE ABSCESS HAS SINCE BEEN RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER STATED THAT THE REPAIR OF THE PATIENT'S BOWEL INJURY WAS NOT PERFORMED AT THE HOSPITAL AND WAS MOST LIKELY PERFORMED AT A DIFFERENT HOSPITAL. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT." }, { "mdr_text_key": "18074849", "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 FOR THE PATIENT'S OPERATIVE COMPLICATIONS. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2014. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN." } ], "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": "" } ] }