{ "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": "2955842-2013-03540", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130913", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20081222", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130913", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "461428", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130913", "brand_name": "DA VINCI S 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": "IS 2000 A5.1P8", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20130913", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "28 YR", "patient_sex": "", "patient_weight": "119", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Fever", "Tachycardia", "Peritonitis" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3346673", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130816", "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": "3816223", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS AND OPERATIVE REPORT OF A PATIENT WHO SUFFERED POST- SURGICAL COMPLICATIONS AFTER UNDERGOING A RIGHT HEMI COLECTOMY WITH RIGHT ILEAL REVISION DA VINCI SURGICAL PROCEDURE. THE PATIENT WAS REFERRED TO GENERAL SURGERY CLINIC AFTER SHE WAS FOUND TO HAVE A LONG ILEAL SEGMENT OF CROHN'S AND WORSENING ABDOMINAL PAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL. AFTER EXPLAINING THE RISK AND BENEFITS OF THE PROCEDURE INCLUDING RISK OF INTERNAL HERNIA, BLEEDING, LEAK, RECURRENCE, NEED FOR REOPERATION THE PATIENT CONTINUED TO UNDERGO A DA VINCI RIGHT HEMICOLECTOMY WITH EXTENDED RIGHT ILEAL RESECTION WITH TWO- LAYER HAND SEWN ANASTOMOSIS ON (B)(6) 2012. IN THE OPERATIVE REPORT THERE IS NO EVIDENCE THAT THE DA VINCI SYSTEM OR INSTRUMENT MALFUNCTIONED. THE CROHN'S DISEASE RESECTION TOOK PLACE AT MID BOWEL LEVEL, ANASTOMOSIS WAS CREATED USING STAPLES WHICH DID NOT SHOW ANY EVIDENCE OF BLEEDING. THE MESENTERIC DEFECTS WERE CLOSED USING RUNNING 2.0 SILK AND THE ABDOMEN WAS WELL IRRIGATED. THERE WAS NO EVIDENCE OF FRANK PUS AND ALL DISSECTED AREAS WERE FOUND TO BE HEMOSTATIC. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON POSTOPERATIVE DAY 3, THE PATIENT WAS NOTED TO HAVE A PERSISTENT FEVER AND TACHYCARDIA AND WAS FOUND TO HAVE PERITONITIS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A DIAGNOSTIC LAPAROSCOPY THAT WAS CONVERTED TO AN EXPLORATORY LAPAROTOMY WITH RESECTION OF THE ANASTOMOSIS DUE TO NOTED ANASTOMATIC LEAK IN THE CHRON'S DISEASE AND RESECTED AREA. THE PATIENT HAD A NASOGASTRIC TUBE PLACED FOLLOWING THE SECOND SURGERY. ON POSTOPERATIVE DAY 4 FROM HER SECOND SURGERY, THE PATIENT WAS NOTED TO HAVE FEVER AGAIN AND PURULENT DRAINAGE FROM HER WOUND. ON POSTOPERATIVE DAY 6 FROM HER SECOND SURGERY, THE PATIENT WAS STARTED ON INTRAVENOUS PRIMAXIN. HER BOWEL FUNCTION SLOWLY RETURNED AND THE PATIENT'S NG TUBE WAS DISCONTINUED ON POSTOPERATIVE DAY 9 FROM THE SECOND SURGERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITH PRESCRIBED WOUND CARE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "11091911", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT, ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2012 AND NO MALFUNCTION WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI RIGHT HEMICOLECTOMY AND RIGHT ILEAL RESECTION PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS." } ], "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": "" } ] }