{ "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": "2955842-2013-04309", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131010", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130327", "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": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "518253", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131010", "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, A6.0P7", "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": [ "Device Operates Differently Than Expected" ], "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": "20131010", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "94", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Fistula", "Pain", "Injury" ] } ], "distributor_city": "", "date_report": "20130910", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3405339", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130910", "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": "3885029", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH SALPINGECTOMY PROCEDURE ON (B)(6) 2013 WHO REPORTEDLY SUSTAINED A BOWEL INJURY AND DEVELOPED A FISTULA FOLLOWING THE SURGICAL PROCEDURE. ACCORDING TO THE (B)(6) 2013 DA VINCI HYSTERECTOMY OPERATIVE REPORT, THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS METRORRHAGIA. THE PATIENT'S UTERUS AND ADNEXA WERE NOTED TO BE NORMAL SIZE. THERE WERE EXTENSIVE SEVERE DENSE ADHESIONS OF THE SMALL INTESTINE THAT EXTENDED FROM THE XIPHOID PROCESS OVER THE UMBILICUS AND DOWN TO THE PUBIC BONE. NO EVIDENCE OF ENTEROTOMY OR CYSTOTOMY WAS NOTED. THE OPERATIVE REPORT INDICATED THAT THE BOWEL ADHESIONS THAT EXTENDED INTO THE FASCIA FROM THE PATIENT'S PRIOR SURGERY. CYSTOURETHROSCOPY SHOWED NO EVIDENCE OF A BLADDER INJURY. NO COMPLICATIONS WERE NOTED AND THE PATIENT'S POST-OP CONDITION WAS STABLE. THE PATIENT'S DISCHARGE SUMMARY WAS NOT PROVIDED; HOWEVER, THE (B)(6) 2013 OPERATIVE REPORT INDICATED THAT HER DISPOSITION WAS HOME. THE PATIENT'S MEDICAL RECORDS INDICATED THAT THE PATIENT SOUGHT MEDICAL ATTENTION POST OP DAY 1 AT THE EMERGENCY ROOM FOR ABDOMINAL PAIN BUT WAS RELEASED THE SAME DAY. ON POST OP DAY 2, THE PATIENT RETURNED TO THE ER WITH ABDOMINAL PAIN. A CT SCAN SHOWED SOME PLEURAL EFFUSIONS OR PNEUMOTHORAX WAS NOTED BUT IT WAS NOT DEFINITIVE IF THERE WAS ANY BOWEL INJURY. THE NEXT DAY, THE PATIENT HAD SUCCUS ENTERICUS COMING OUT FROM ONE OF THE LATERAL PORT SITES. SHE WAS IMMEDIATELY TAKEN TO SURGERY WHERE A SMALL BOWEL INJURY WAS FOUND. THE BOWEL WAS RESECTED AND REANASTOMOSED. THE PATIENT DID WELL FOR 4 DAYS UNTIL ANOTHER LEAK WAS FOUND. THE PATIENT WAS BROUGHT BACK TO SURGERY WHERE AN APPARENT SEROSAL INJURY HAD OPENED UP NEAR THE REANASTOMOSIS WAS DONE. IT WAS NOTED THAT THE INJURY WAS RELATED TO THE LYSIS OF ADHESIONS THAT WAS QUITE SIGNIFICANT DURING THE HYSTERECTOMY. SUBSEQUENT LEAKS WERE FOUND AND THE PATIENT UNDERWENT 2 ADDITIONAL LAPAROSCOPIC EXPLORATORY ON (B)(6) 2013 AND ANOTHER UNSPECIFIED DATE. SHE WAS DISCHARGED ON (B)(6) 2013 WITH A DIAGNOSIS OF A SMALL BOWEL FISTULA AFTER THE ROBOTIC HYSTERECTOMY AND 3 EXPLORATIONS. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED." }, { "mdr_text_key": "11147333", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. 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. 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 SI SURGICAL 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": "" } ] }