{ "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": "2955842-2013-03505", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130912", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120814", "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": "459742", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130912", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250815", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Abdominal Pain", "Abscess", "Bradycardia", "Chest Pain", "Embolus", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Abnormal Vaginal Discharge", "Organ Dehiscence", "Constipation" ] } ], "distributor_city": "", "date_report": "20130816", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3345310", "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": "15542612", "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 POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED AFTER THE SURGICAL PROCEDURE WAS STARTED. 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)(4) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED VAGINAL CUFF DEHISCENCE AFTER UNDERGOING A DA VINCI SI SURGICAL PROCEDURE. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "15180637", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT AND INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF PELVIC PAIN AND DYSFUNCTIONAL UTERINE BLEEDING. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI SI SURGICAL PROCEDURE, NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. THE SURGEON STATED THAT THE VAGINAL CUFF WAS CLOSED USING A V-LOCK 180 IN A RUNNING FASHION AND HEMOSTASIS WAS ASSURED. IN ADDITION A SHEET OF INTERCEED, AN ABSORBABLE ADHESION BARRIER, WAS PLACED OVER THE VAGINAL CUFF. A CYSTOSCOPY WAS ALSO PERFORMED TOWARDS THE END OF THE PROCEDURE AND NO EVIDENCE OF AN INJURY OR BLEEDING WAS OBSERVED. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR REPORTED COMPLAINTS OF CHEST PAIN, SHORTNESS OF BREATH, AND LEFT CALF PAIN. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE PATIENT'S CHEST REVEALED SMALL BILATERAL LOWER LOBE PULMONARY EMBOLI AND NO INFILTRATES. SHE WAS DISCHARGED ON (B)(6) 2012. ADDITIONAL CTA'S OF THE PATIENT'S CHEST WERE PERFORMED ON (B)(6) 2012 AND NO EVIDENCE OF PULMONARY EMBOLI WERE FOUND. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS LOWER ABDOMINAL/PELVIC PAIN. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT STATED THAT SHE HAD BEEN VERY CONSTIPATED RECENTLY AND STARTED PUSHING A LOT TODAY. THE PATIENT ALSO STATED THAT THERE WAS SOMETHING COMING OUT OF MY VAGINA. THE PATIENT SUBSEQUENTLY UNDERWENT AN EXPLORATORY LAPAROTOMY WITH REDUCTION OF EVISCERATED SMALL BOWEL AND REPAIR OF VAGINAL CUFF DEHISCENCE. SHE WAS DISCHARGED HOME FROM THE HOSPITAL. ON (B)(6) 2012, A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED A PELVIC ABSCESS. THE PATIENT UNDERWENT CT-GUIDED ASPIRATION OF THE PELVIC ABSCESS ON (B)(6) 2012. CT SCANS OF THE PATIENT'S ABDOMEN AND PELVIS WERE PERFORMED ON (B)(6) 2012. THE CT SCANS SHOWED DECREASED SIZING OF THE PELVIC ABSCESS. ON (B)(6) 2012, THE PATIENT WAS EVALUATED FOR REPORTED COMPLAINTS OF CHEST PAIN AND SHORTNESS OF BREATH. A CTA REVEALED A STABLE PULMONARY EMBOLISM IN THE RIGHT LOWER PULMONARY LOBE. A COMPARATIVE CTA PERFORMED ON (B)(6) 2013, SHOWED A STABLE AND SMALL PULMONARY EMBOLISM. A CHEST X-RAY WAS FOUND TO BE NORMAL. ON (B)(6) 2013, THE PATIENT WAS EVALUATED FOR RECURRING CHEST PAIN. A CTA OF THE PATIENT'S CHEST SHOWED FURTHER IMPROVEMENT OF THE SMALL VOLUME PULMONARY EMBOLISM. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CONDITION SINCE (B)(6), 2013, TO THE PRESENT TIME." } ], "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": "" } ] }