{ "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": "2955842-2013-03190", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20071107", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "417065", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "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 A6.0P6", "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Diarrhea", "Fever", "Nausea", "Pain", "Swelling", "Vomiting", "Injury", "Abdominal Distention" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306668", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "18854566", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED AN INJURY TO HER SMALL BOWEL DURING THE SURGICAL PROCEDURE. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE PATIENT DEVELOPED A PELVIC ABSCESS POST-OPERATIVELY. THE PATIENT'S MEDICAL RECORDS STATE THE PATIENT UNDERWENT A ROBOTIC ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND A BILATERAL PELVIC AND PARAAORTIC LYMPHADENECTOMY PROCEDURE. AFTER CLOSURE AND INSPECTION OF THE VAGINAL CUFF, A SMALL \"SEROTOMY\" WAS FOUND IN THE SIGMOID COLON. THE \"SEROTOMY\" WAS REPAIRED WITH SUTURES. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE SURGEON STATED IN THE OPERATIVE REPORT THAT THERE WERE NO COMPLICATIONS AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITH ORAL PAIN MEDICATIONS. AT AN UNSPECIFIED TIME RIGHT AFTER THE SURGERY WAS COMPLETED, THE PATIENT DEVELOPED ABDOMINAL DISTENSION FROM ACCUMULATION OF LYMPHATIC FLUID. AFTER THE FIRST WEEK POSTOP, THE PATIENT DEVELOPED COPIOUS DRAINAGE OF LYMPHATIC FLUID FROM THE VAGINA. SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2007 WITH REPORTED COMPLAINTS OF A SWOLLEN RIGHT LOWER LEG AND FEVER. A WEEK PRIOR TO ADMISSION, THE PATIENT HAD DEVELOPED FLU-LIKE SYMPTOMS WITH BODY ACHES, DIARRHEA, NAUSEA, AND VOMITING. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED A PELVIC ABSCESS IN THE RIGHT LOWER QUADRANT. ON (B)(6) 2007, THE PATIENT UNDERWENT A CT-GUIDED DRAINAGE OF THE ABSCESS AND A TRUNCULOSE DRAIN WAS PLACED. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2007, WITH ORAL ANTIBIOTICS. ACCORDING TO THE DOCUMENTATION PROVIDED, THE DRAIN WAS REMOVED APPROXIMATELY 2 MONTHS LATER. NO FURTHER INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "19208803", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AFTER UNDERGOING A DA VINCI HYSTERECTOMY 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": "" } ] }