{ "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": "2955842-2013-04308", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131010", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120910", "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": "20131011", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "516819", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131010", "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": "20250818", "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": "20131010", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "48 YR", "patient_sex": "", "patient_weight": "96", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Adhesion(s)", "Edema", "Erythema", "Low Blood Pressure/ Hypotension", "Pain", "Pleural Effusion", "Respiratory Distress", "Sepsis", "Tachycardia", "Numbness", "Increased Respiratory Rate" ] } ], "distributor_city": "", "date_report": "20130910", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3405323", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130910", "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": "3777257", "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 THAT UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND LEFT SALPINGO-OOPHORECTOMY PROCEDURE WITH EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS MENORRHAGIA, UTERINE FIBROIDS, AND HISTORY OF MODERATE CERVICAL DYSPLASIA. ACCORDING TO THE MEDICAL RECORDS PROVIDED, INFORMED CONSENT WAS OBTAINED FROM THE PATIENT PRIOR TO THE DA VINCI SI SURGICAL PROCEDURE. BASED ON THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. HOWEVER, DURING THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SEVERE PELVIC ADHESIVE DISEASE AND ABDOMINAL ADHESIVE DISEASE WITH FINDINGS OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL LINING, THE RIGHT SIDE OF THE PELVIS AND ABDOMINAL WALL, AS WELL AS THE PELVIC SIDEWALLS. THE PATIENT'S LEFT TUBE AND OVARY WERE ALSO FOUND TO BE SEVERELY ADHERED TO THE LEFT PELVIC SIDEWALL. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS EXTUBATED AND TAKEN TO THE RECOVERY ROOM AWAKE, ALERT, AND IN STABLE CONDITION. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. FROM (B)(6) 2012, MULTIPLE CT SCANS AND X-RAYS WERE PERFORMED ON THE PATIENT'S CHEST AND ABDOMEN DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RESPIRATORY DISTRESS AND SEPSIS. ON THE EVENING OF POST-OP DAY 1 ((B)(6) 2012), THE PATIENT BEGAN TO HAVE A REPORTED COMPLAINT OF INCREASED ABDOMINAL PAIN WITH SYMPTOMS OF TACHYCARDIA, TACHYPNEA, AND HYPOTENSION. ON (B)(6) 2012, A CT SCAN OF THE PATIENT'S ABDOMEN REVEALED INCREASED AMOUNTS OF FLUID ADJACENT TO THE LIVER AND WITHIN THE ABDOMEN. LATER THAT SAME DAY, AN EXPLORATORY LAPAROTOMY PROCEDURE WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE A MID-JEJUNAL ENTEROTOMY AND BOWEL CONTENTS IN THE ABDOMEN. A SEGMENTAL RESECTION AND RE-ANASTOMOSIS OF THE SMALL BOWEL WAS THEN PERFORMED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2012, A REPEAT CT SCAN OF THE PATIENT'S ABDOMEN WAS PERFORMED DUE TO INCREASING EDEMA AND ERYTHEMA ON THE LEFT FLANK. THE CT SCAN REVEALED A 5X7.5 CM FLUID AREA JUST ABOVE THE BLADDER WHICH WAS DRAINED THE FOLLOWING DAY BY VASCULAR & INTERVENTIONAL RADIOLOGY (VIR). AT THAT TIME, A PELVIC DRAIN WAS LEFT IN PLACE. ON (B)(6) 2012, A REPEAT CT SCAN SHOWED IMPROVEMENT OF THE PELVIC DRAIN; HOWEVER, A NEW COLLECTION WAS FOUND NEAR THE LIVER. THE PELVIC DRAIN WAS REMOVED AND A NEW VIR DRAIN WAS PLACED INTO THE LIVER FLUID COLLECTION. IN ADDITION, A NEW CENTRAL VENOUS CATHETER WAS PLACED INTO THE LEFT INTERNAL JUGULAR VEIN. ON (B)(6) 2012, THE PATIENT WAS TRANSFERRED TO AN ACUTE CARE CENTER FOR FURTHER MEDICAL MANAGEMENT. AT THE TIME OF TRANSFER, THE PATIENT WAS INTUBATED AND ON A VENTILATOR. ON (B)(6) 2012, THE PATIENT UNDERWENT AN OPEN TRACHEOSTOMY AND RIGHT THORACENTESIS DUE TO ACUTE RESPIRATORY FAILURE AND BILATERAL PLEURAL EFFUSIONS. DURING THE COURSE OF THE PATIENT'S HOSPITALIZATION, HER WBC'S TRENDED DOWNWARD. SHE WAS DISCHARGED TO A REHABILITATION CENTER ON (B)(6) 2012 AND SUBSEQUENTLY DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS EVALUATED BY A PHYSICIAN FOR REPORTED POST-SURGICAL COMPLAINTS OF ARM NUMBNESS AND PAIN SINCE (B)(6) 2012. DUE TO THE COMPLAINTS OF ARM AND SHOULDER PAIN, THE PATIENT UNDERWENT PHYSICAL THERAPY (PT) ON (B)(6) 2013. ALSO, AN X-RAY OF THE PATIENT'S SHOULDERS WAS PERFORMED ON (B)(6) 2013 DUE TO ONGOING SHOULDER PAIN. DURING A PHYSICIAN'S OFFICE VISIT ON (B)(6) 2013, THE PATIENT WAS ADVISED TO CONTINUE PT. THE PHYSICIAN NOTED THAT ELECTROMYOGRAPHY (EMG) AND NERVE CONDUCTION TESTS PERFORMED IN (B)(6) 2013 WERE INTERPRETED AS BEING NEGATIVE. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE PHYSICIAN'S OFFICE VISIT FROM (B)(6) 2013." }, { "mdr_text_key": "11147711", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL 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. 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)(6) 2012. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT WAS FOUND TO HAVE SUSTAINED A MID-JEJUNAL ENTEROTOMY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED." } ], "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": "" } ] }