{ "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": "2955842-2013-04941", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100608", "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": "20131104", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "563018", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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 A5.1P8", "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", "Extrusion" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20131101", "sequence_number_treatment": [ "DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "56 YR", "patient_sex": "", "patient_weight": "80", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Low Blood Pressure/ Hypotension", "Hypoxia", "Pain", "Urinary Retention", "Abdominal Distention", "Vascular Dissection", "Constipation" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444205", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "3950787", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S SUPRACERVICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY FOR SYMPTOMATIC FIBROIDS THAT DISPLACED THE ENDOMETRIAL CANAL, DYSFUNCTIONAL IRREGULAR HEAVY UTERINE BLEEDING, AND ANEMIA ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH ALL OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2010, HOSPITALIST CONSULTATION (B)(6) 2010, DISCHARGE SUMMARY (B)(6) 2010, MEDICAL CONSULTATION (B)(6) 2010, INTRAOPERATIVE GEN. SURGICAL CONSULTATION (B)(6) 2010, DISCHARGE SUMMARY (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER PLACEMENT OF THE UTERINE MANIPULATOR, A SUBUMBILICAL INCISION WAS MADE THROUGH A PREVIOUS LAPAROSCOPIC SCAR AND A TROCAR INSERTED. AFTER PLACEMENT OF 3 ADDITIONAL TROCARS THE LEFT FALLOPIAN TUBE WAS CLAMPED, CAUTERIZED AND CUT WITH THE LIGASURE DEVICE LAPAROSCOPICALLY. MOBILIZATION OF THE UTERUS WAS CONTINUED BY TAKING DOWN FIRST THE LEFT-SIDED LATERAL LIGAMENTS (UTERO-OVARIAN LIGAMENT, BROAD LIGAMENT TO THE LEVEL OF THE LEFT ROUND LIGAMENT). THE BLADDER FLAP WAS THEN DEVELOPED WITH THE LIGASURE DEVICE. SUBSEQUENTLY, THE RIGHT INFUNDIBULOPELVIC LIGAMENT WAS MOBILIZED DOWN TO THE LEVEL OF THE MESOSALPINX WITH THE LIGASURE DEVICE. AT THIS TIME, THE URETER WAS NOTED TO BE INTIMATELY CLOSE TO THE DISSECTION. THE PATIENT WAS GIVEN ONE AMP OF INDIGO CARMINE IV, AND AT NO TIME THROUGHOUT THE PROCEDURE WAS THERE EVER ANY EVIDENCE OF A RENT IN THE URINARY TRACT SYSTEM. THE RIGHT UTERINE VESSELS WERE CLAMPED, CAUTERIZED AND CUT USING THE LIGASURE DEVICE. THEN THE ROBOT WAS DOCKED. THE BLADDER FLAP WAS CREATED WITH BOTH SHARP AND BLUNT DISSECTION USING THE BIPOLAR FENESTRATED CAUTERY INSTRUMENT AND THE UNIPOLAR HOT SHEARS. THE LEFT UTERINE VESSELS AND PEDICLE WERE CAUTERIZED AND INCISED AND THE COLPOTOMY PERFORMED. THE RIGHT TUBE AND OVARY WERE REMOVED BECAUSE OF DENSE ADHESIONS TO THE RIGHT BROAD LIGAMENT AND TO THE RIGHT CORNUAL AREA. THE EDGES OF THE INTERNAL CERVICAL OS WERE CAUTERIZED WITH MONOPOLAR HOT SHEARS, THE DA VINCI ROBOT WAS UNDOCKED AND THE UTERUS, RIGHT FALLOPIAN TUBE AND OVARY MORCELLATED AND REMOVED. A BACITRACIN SOAKED PIECE OF INTERCEED WAS PLACED AT THE BED OF THE CERVIX. INSPECTION OF THE URETERS SHOWED NO EVIDENCE OF TRAUMA. HOWEVER, IT IS TO BE NOTED THAT THE RIGHT URETER WAS INTIMATELY CLOSE TO THE DISSECTION THROUGH THE RIGHT BROAD LIGAMENT; HOWEVER, THERE WAS NO EVIDENCE OF ANY TRAUMA TO THE RIGHT URETER. AT THE TERMINATION OF THE PROCEDURE, THE FOLEY WAS DRAINING BLUE-TINGED URINE AND THROUGHOUT THE PROCEDURE THERE WAS NO EVIDENCE OF ANY BLUE DYE IN THE PERITONEAL CAVITY. THE PATIENT DID WELL POSTOPERATIVELY UNTIL SHE STARTED HAVING HYPOTENSION, HYPOXEMIA AND DECREASED URINE OUTPUT ON POSTOPERATIVE DAY 2 FOR WHICH SHE WAS SEEN BY THE HOSPITALISTS ON (B)(6) 2010. HER SHORTNESS OF BREATH WITH HYPOXEMIA WAS CONSIDERED MULTIFACTORIAL, PROBABLY RELATED TO HER SEVERE ANEMIA THAT WAS CORRECTED WITH 2 UNITS OF RBC AND HER HYPOTENSION. AN ACUTE RENAL INSUFFICIENCY WAS CONSIDERED TO BE A PRERENAL AZOTEMIA RELATED TO HER HYPOTENSION. AFTER THE SYMPTOMS RESOLVED THE PATIENT WAS DISCHARGED ON (B)(6) 2010 IN GOOD CONDITION AND ON A REGULAR DIET. ON (B)(6) 2010 THE PATIENT HAD SEEN HER PRIMARY CARE PHYSICIAN FOR INCREASING PELVIC PAIN, ABDOMINAL DISTENSION WITH BLOATING AND DIFFICULTY WITH BOWEL MOVEMENTS AND UNDERWENT A CT SCAN OF THE PELVIS AND ABDOMEN, WHICH SHOWED A 13.8 X 12.9 CYSTIC MASS IN THE PELVIS. SHE WAS READMITTED THE SAME DAY FOR AN EXPLORATORY LAPAROTOMY. ON (B)(6) 2010 SHE UNDERWENT AN EXPLORATORY LAPAROTOMY WITH DRAINAGE OF A PELVIC URINOMA, STENTING OF THE RIGHT URETER USING A DOUBLE-J STENT AND REAPPROXIMATION OF THE DEFECT RIGHT URETER WITH 2 FIGURE-OF-EIGHT VICRYL 3-0 SUTURES. (BLOOD LOSS: 200CC). POSTOPERATIVELY, THE PATIENT HAD DEVELOPED AN ILEUS WHICH REQUIRED TOTAL PARENTERAL NUTRITION, 2 RBC WERE TRANSFUSED FOR ANEMIA. ON (B)(6) 2010 THE PATIENT WAS SUBSEQUENTLY SENT HOME IN GOOD CONDITION, ON A SOFT DIET, AND WITH THE FOLEY CATHETER STILL IN PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE." }, { "mdr_text_key": "11214013", "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 FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI S 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": "" } ] }