{ "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": "2955842-2013-04940", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120716", "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": "562166", "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": "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "38 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abscess", "Hematoma", "Low Blood Pressure/ Hypotension", "Pneumonia", "Respiratory Distress", "Sepsis", "Abdominal Distention", "Multiple Organ Dysfunction Syndrome" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3444204", "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": "11245342", "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 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": "3856538", "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 SI LYSIS OF ADHESIONS, RELEASE OF RIGHT OVARY AND TUBE FROM SIDEWALL, LEFT UTEROSACRAL NERVE ABLATION, EXCISION OF ADHESIONS CONSISTENT FOR ENDOMETRIOSIS AND REMOVAL OF A PARATUBAL CYST FOR CHRONIC PELVIC PAIN, DYSMENORRHEA AND A HISTORY OF ENDOMETRIOSIS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH ALL OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2012, (B)(6) 2012 GASTROENTEROLOGY CONSULTATION FOR ABDOMINAL PAIN (B)(6) 2012, OR REPORT (B)(6) 2012, (B)(6) 2012, (B)(6) 2012 ; RENAL CONSULTATION FOR INCREASING CREATININE 07/30/2012, EYES, NOSE, THROAT (ENT) CONSULTATION FOR TRACHEOTOMY (B)(6) 2012, INTERNAL MEDICINE CONSULTATION FOR ELEVATED BLOOD PRESSURE (B)(6) 2012, CARDIOLOGY CONSULTATION FOR TACHYCARDIA 08/16/2012, DISCHARGE SUMMARY (B)(6) 2012 AND (B)(6) 2012. 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. A V-CARE DEVICE WAS PLACED INTRAVAGINALLY AND A PNEUMPERITONEUM CREATED THROUGH AN INCISION THAT WAS CREATED WITH INDIRECT INSERTION TECHNIQUE. 3 ADDITIONAL PORTS WERE PLACED WITHOUT DIFFICULTY. THERE WERE NO ADHESIONS INVOLVING THE BOWEL, APPENDIX, SIGMOID COLON. THE UPPER ABDOMEN AND LIVER WERE INSPECTED AND NO ABNORMALITIES WERE OBSERVED. SEVERAL PARATUBAL CYSTS ON THE LEFT WERE REMOVED AND IN THE CUL-DE-SAC THERE WERE SMALL BURNED OUT ADHESIONS AND STELLATE LESIONS CONSISTENT WITH ENDOMETRIOSIS ON THE LEFT THAT WERE REMOVED AFTER VISUALIZING THE URETER. A LAPAROSCOPIC UTEROSACRAL NERVE ABLATION WITH TRANSECTION OF THE LIGAMENT ON THE LEFT SIDE WAS PERFORMED. DUE TO ALL THE ADHESIONS, IT WAS NOTED THIS WAS ALL THE WAY FROM HER URETER WITH A COUPLE OF SPOTS SUSPICIOUS FOR ENDOMETRIOSIS THAT WERE FULGURATED. ON THE RIGHT SIDE, THE TUBE AND OVARY, WHICH WERE ATTACHED TO THE SIDEWALL, WERE FREED WITH HOT SHEARS BY RELEASING ADHESIONS. THE URETER WAS WATCHED CLOSELY DURING THE WHOLE TIME AND NO INJURY COULD BE NOTED. A KINK IN THE MID-SECTION OF THE MOBILIZED RIGHT TUBE WAS RELEASED WITH REMOVAL OF ADHESIONS. AFTER AN INITIALLY UNCOMPLICATED COURSE, ON POSTOPERATIVE DAY 3, THE PATIENT COMPLAINED ABOUT ABDOMINAL DISTENTION, PAIN, NAUSEA AND VOMITING AND A GASTROENTEROLOGIST WAS CONSULTED. THE SAME DAY, SHE EXPERIENCED A CARDIAC ARREST AND WAS DETERMINED TO HAVE BEEN SEPTIC AND AN INTRAABDOMINAL PERITONEAL LAVAGE DEMONSTRATED FRANK STOOL IN THE ABDOMEN. ON (B)(6) 2012, SHE WAS TAKEN TO THE OPERATING ROOM. AN EXPLORATORY LAPAROTOMY WAS PERFORMED WITH PERITONEAL LAVAGE WITH BACITRACIN/GENTAMICIN SOLUTION, SMALL BOWEL RESECTION LEFT IN DISCONTINUITY AT THE TERMINAL ILEUM FOR A PERFORATION AT THE MESENTERIC SURFACE, AND A TEMPORARY ABDOMINAL CLOSURE WITH ABTHERA WOUND VACUUM ASSISTED CLOSURE (VAC) APPLIANCE WAS APPLIED. SHE HAS SINCE UNDERGONE 3 SUBSEQUENT OPERATIONS TO REANASTOMIZE THE SMALL BOWEL ((B)(6) 2012) AND ALSO TO CLOSE HER ABDOMEN (COMPONENT SEPARATION OF ABDOMINAL WALL WITH PRIMARY FASCIA CLOSURE WITH ONLAY 20X20 CM BIOLOGIC MESH ON (B)(6) 2012). SINCE (B)(6) 2012, SHE HAS BEEN ON THE VENTILATOR FOR REASONS OF RESPIRATORY DISTRESS RELATED TO HER SEPSIS, PNEUMONIA AND HER ABDOMINAL DISTENTION AND SHE RECEIVED A TRACHEOSTOMY ON (B)(6) 2012 FOR PROLONGED RESPIRATORY FAILURE. AS A RESULT OF THE MULTI-ORGAN FAILURE DUE TO AN ONGOING SEPTIC CONDITION, SHE ALSO DEVELOPED AN ACUTE KIDNEY INJURY REQUIRING CRRT, LIKELY SECONDARY TO HYPOPERFUSION FROM ABDOMINAL COMPARTMENT SYNDROME/SEPSIS, AS WELL AS AN UTI AND A SINUS TACHYCARDIA WITH HYPERTENSION REFRACTORY TO MEDICAL THERAPY. ON (B)(6) 2012, THE PATIENT HAS HAD PERSISTENTLY WORSENING OF OLIGURIA AND HYPOTENSION AS WELL AS A SEVERELY DISTENDED AND TENSE ABDOMEN. IT WAS FELT THAT THE PATIENT MAY BE DEVELOPING THESE SIGNS AND SYMPTOMS DUE TO ABDOMINAL COMPARTMENT SYNDROME AND SHE WAS TAKEN BACK TO THE OPERATING ROOM FOR ANOTHER EXPLORATORY LAPAROTOMY, REVISION OF THE ANTERIOR ABDOMINAL WALL CLOSURE AND EVACUATION OF 900CC OLD HEMATOMA. SINCE THEN THE PATIENT PROGRESSED WELL. VENTILATOR WEANING WAS STARTED AND THE PATIENT WAS ABLE TO TOLERATE CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) AND TRACH COLLAR TRIALS HAVE BEEN INITIATED IN THE INTENSIVE CARE UNIT, WHICH SHE TOLERATED WELL. THE PATIENT WAS TRANSFERRED TO LONG-TERM ACUTE CARE ON (B)(6) 2012 WITH TUBE FEEDING AND A PERSISTENT ABDOMINAL WOUND. SHE WAS DECANULATED ON (B)(6) 2012 AND HAD AN UNEVENTFUL REST OF HER HOSPITALIZATION AND WAS TRANSFERRED TO A REHABILITATION FACILITY ON (B)(6) 2012. ON (B)(6) 2012 AN ABDOMINAL WALL ABSCESS HAD TO BE INCISED AND DRAINED." } ], "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": "" } ] }