{ "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": "2955842-2013-03162", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110512", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409870", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": [ "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": "20250811", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "32 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Flatus", "Inflammation", "Pelvic Inflammatory Disease", "Abnormal Vaginal Discharge" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305659", "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": "19563795", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY AND RIGHT SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS FOUND TO HAVE BOWEL ADHESIONS TO THE ANTERIOR UTERINE SURFACE AND OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. THE OPERATIVE REPORT STATES THAT GREAT USE OF CAUTERY WAS USED DURING THE PROCEDURE. A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED AND FOUND TO BE UNREMARKABLE. THE DIAGNOSTIC CYSTOSCOPY ALSO REVEALED GOOD FLOW FROM BOTH URETERAL ORIFICES. THE PATIENT WAS REPORTEDLY DISCHARGED ON AN UNSPECIFIED DATE AFTER AN UNREMARKABLE STAY. ON AN UNSPECIFIED DATE IN LATE (B)(6) 2011, THE INFORMATION INDICATED THAT THE PATIENT BEGAN EXPERIENCING BROWN VAGINAL DISCHARGE AS WELL AS FLATULENCE FROM HER VAGINA. BASED ON VISITS WITH A PHYSICIAN IN LATE (B)(6) 2011, THE PHYSICIAN NOTED THAT THE PATIENT WAS HAVING INTERCOURSE WITH HER SPOUSE. HOWEVER, THE PATIENT ADAMANTLY DENIED THAT THIS WAS THE CASE AND SHE RECALLED HAVING SEXUAL INTERCOURSE WITH HER HUSBAND NEAR HIS BIRTHDAY IN LATE (B)(6) 2011. THE PHYSICIAN REFERRED THE PATIENT TO A COLO-RECTAL SURGEON. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO A HOSPITAL AND UNDERWENT A DIAGNOSTIC LAPAROSCOPY WHICH WAS CONVERTED TO AN OPEN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND INCIDENTAL APPENDECTOMY. DURING THE SURGERY, IT WAS NOTED THAT THE PATIENT HAD MARKED INFLAMMATION IN THE PELVIC CAVITY AS WELL AS A HOLE IN THE COLON, WITH A FISTULA COMMUNICATING FROM THE DISTAL ILEUM. IT WAS STATED THAT THESE CONDITIONS CAN BE ATTRIBUTED TO THE USE OF MONOPOLAR ENERGY FROM THE PRIOR SURGERY. ON (B)(6) 2011, THE PATIENT HAD A REVISION PROCEDURE TO THE VAGINAL CUFF. IT WAS NOTED THAT THERE WAS NO IDENTIFIABLE CUFF DEHISCENCE DURING THE SURGICAL PROCEDURE. THE PATIENT'S VAGINAL CUFF WAS REPORTED REINFORCED. SHE WAS HOSPITALIZED FOR AN UNSPECIFIED DURATION. ON (B)(6) 2012, THE PATIENT UNDERWENT A COLONOSCOPY PROCEDURE AND A DIGITAL EXAM OF THE VAGINA REVEALED DISCHARGE WITH SOME STOOL AT FINGERTIP. IT WAS INDICATED THAT THE PROCEDURE FOUND SOME CONNECTION BETWEEN THE BOWEL AND VAGINA. ON (B)(6) 2012, THE PATIENT UNDERWENT AN UNSPECIFIED SECOND PROCEDURE FOR FURTHER EVALUATION. NO CLINICAL INFORMATION WAS PROVIDED REGARDING THE SECOND PROCEDURE. THE INFORMATION PROVIDED STATES THAT HER SYMPTOMS HAD IMPROVED BUT SHE WAS STILL NOT BACK TO HER NORMAL STATE." }, { "mdr_text_key": "19839158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION AVAILABLE, 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 HAVE 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED AN INJURY TO HER COLON AS A RESULT OF UNDERGOING A DA VINCI SURGICAL 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": "" } ] }