{ "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": "2955842-2013-03501", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120214", "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": "20130912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "460308", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20130912", "sequence_number_treatment": [ "DA VINCI S SURG SYS INSTRMNTS, ACCESSORIES AND ES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess", "Adhesion(s)", "Fever", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345253", "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": "3726518", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S PELVIC AND PERI-AORTIC LYMPHNODE DISSECTION, OMENTECTOMY, AND STAGING FOR GRADE IV OVARIAN CANCER ON (B)(6) 2012 DUE TO CANCER OF THE OVARY. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE PATIENT'S POST-OP COURSE WAS UNCOMPLICATED AND ON (B)(6) 2012 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. REPORTEDLY, ON (B)(6) 2012, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM OF ANOTHER AREA HOSPITAL COMPLAINING OF ABDOMINAL PAIN ASSOCIATED WITH FEVER. THE PATIENT WAS TRANSFERRED BACK TO THE HOSPITAL WHERE THE INITIAL SURGICAL PROCEDURE WAS PERFORMED AND UNDERWENT A CT SCAN AND AN EXPLORATORY LAPAROTOMY. THE CT SCAN REVEALED A PELVIC ABSCESS AND DURING THE LAPAROTOMY PROCEDURE IT WAS DISCOVERED THAT THE PATIENT HAD A PERFORATION OF THE SIGMOID COLON. THE PATIENT UNDERWENT LYSIS OF ADHESIONS, RESECTION OF THE SIGMOID COLON AND A LOOP TRANSVERSE COLOSTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. DURING A FOLLOW-UP VISIT ON (B)(6) 2012 THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIS CT SCAN. THE CT SCAN SHOWED THE COLLECTION OF FLUID IN THE LATERAL PELVIS BILATERALLY. THE LOCATION OF THE FLUID WAS SUGGESTIVE OF POST-OPERATIVE LYMPHOCELES, ADJACENT TO THE LYMPHATIC CHAINES. (B)(6) 2012 THE PATIENT UNDERWENT A CT-GUIDED ASPIRATION OF A PELVIC FLUID COLLECTION PROCEDURE. ACCORDING TO THE PATIENT'S CT SCAN REPORT, NO EVIDENCE OF INFECTION WAS FOUND. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. BASED ON THE MEDICAL RECORDS PROVIDED TO ISI, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY PROCEDURE WITH MOBILIZATION OF THE RECTOSIGMOID STUMP AND ATTEMPT AT REVERSAL OF HER TRANSVERSE LOOP COLOSTOMY ON (B)(6) 2012. THE OP REPORT WAS NOT PROVIDED TO ISI; HOWEVER, THE AMBULATORY PROCEDURE NOTES WERE PROVIDED. PER THE INFORMATION PROVIDED, POST-OPERATIVELY THE PATIENT SLOWLY REGAINED BOWEL FUNCTION. THE PATIENT WAS DISCHARGED HOME TOLERATING A LOW RESIDUAL DIET." }, { "mdr_text_key": "11290322", "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 INJURY SUSTAINED BY THE PATIENT. ON (B)(4) 2013, ISI CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT TO GATHER ADDITIONAL INFORMATION. THE RISK MANAGER INDICATED THAT DUE TO LEGAL CONSTRAINTS AND HIPAA REGULATIONS, THE HOSPITAL IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. 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 INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A POSSIBLE INJURY TO THE SIGMOID COLON DURING A DA VINCI S PERIAORTIC AND PELVIC LYMPH NODE DISSECTION, OMENTECTOMY, AND PERITONEAL BIOPSY PROCEDURE." } ], "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": "" } ] }