{ "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": "2955842-2013-04894", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120117", "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": "562581", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131101", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Abdominal Pain", "Adhesion(s)", "Nausea", "Vomiting", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3443619", "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": "11377596", "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 MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. IN ADDITION, 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 SURGICAL PROCEDURE." }, { "mdr_text_key": "3854571", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012 FOR ADENOCARCINOMA OF THE PROSTATE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. 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. VISUALIZATION OF THE INTRA-PERITONEAL CAVITY REVEALED SOME INTRA-ABDOMINAL ADHESIONS IN THE RIGHT UPPER QUADRANT AND IN THE PERIUMBILICAL REGION. SHARP DISSECTION WAS USED TO TAKE DOWN THE OMENTAL ADHESIONS AND A FEW SMALL BOWEL ADHESIONS. INSPECTION OF THE INTESTINES REVEALED NO INJURY. THE PATIENT WAS VERY THIN, SO THE TROCARS WERE PLACED CLOSER TO EACH OTHER THAN NORMAL. A MINIMAL NERVE SPARING PROCEDURE WAS PERFORMED BILATERALLY SECONDARY TO HIS AGGRESSIVE CANCER. OOZING FROM THE DORSAL VENOUS COMPLEX WAS NOTED AND LIGATED WITH SUTURES. GOOD HEMOSTASIS WAS NOTED THROUGHOUT THE PROCEDURE. A BILATERAL LYMPH NODE DISSECTION WAS PERFORMED FROM THE LEVEL OF THE ILIAC VESSELS TO THE OBTURATOR NERVE AND VESSELS POSTERIORLY TO THE PELVIC SIDEWALL, TO THE BLADDER MEDIALLY. NO INJURY OCCURRED TO THE VESSELS. NO INJURY OCCURRED WITH TROCAR CLOSURE. BLOOD LOSS WAS 300 ML. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS SENT TO THE RECOVERY ROOM IN STABLE CONDITION. HE WAS DISCHARGED ON (B)(6) 2012 FOR A TOTAL HOSPITAL STAY OF FOUR DAYS. ON (B)(6) 2012, PATIENT PRESENTED WITH NAUSEA, VOMITING AND ABDOMINAL PAIN. ON (B)(6) 2012, HE UNDERWENT A LAPAROSCOPIC EXAM THAT WAS CONVERTED TO OPEN WITH AN EXPLORATORY LAPAROTOMY FOR SMALL-BOWEL OBSTRUCTION. DUE TO DISCOMFORT USING THE LAPAROSCOPIC INSTRUMENTS AND CAUSING SOME LEAKAGE FROM THE BOWEL, THE PROCEDURE WAS CONVERTED TO OPEN. A LAPAROSCOPIC CHOLECYSTECTOMY WAS PERFORMED. THE LIVER AND GALLBLADDER HAD SIGNIFICANT ADHESIONS. ON (B)(6) 2012, HE PRESENTED WITH WOUND DEHISCENCE AND PERSISTENT POSTOPERATIVE SMALL BOWEL OBSTRUCTION. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND MULTIPLE ADHESIONS WERE NOTED. THREE INCHES OF SMALL BOWEL WERE REMOVED. A PATHOLOGY REPORT DATED (B)(6) 2012 WAS PROVIDED. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE PATHOLOGY REPORT OF (B)(6) 2012." } ], "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": "" } ] }