{ "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": "2955842-2013-04306", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131010", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110829", "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": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "515100", "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": [ "Break", "Leak/Splash" ], "reporter_state_code": "CA", "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": "55 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Air Embolism", "Hemorrhage/Blood Loss/Bleeding", "Ischemia", "Pulmonary Infarction", "Sepsis", "Tachycardia", "Peritonitis", "Respiratory Failure", "Abdominal Distention", "Alteration In Body Temperature" ] } ], "distributor_city": "", "date_report": "20130910", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3405417", "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": "3879438", "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 RIGHT AND LEFT HEMICOLECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT ALSO UNDERWENT A TRU-CUT LIVER BIOPSY. THE LEGAL COMPLAINT ALLEGES THAT THE PATIENT'S COLON TISSUE WAS POTENTIALLY DAMAGED BY A ROBOTIC ARM ATTACHMENT THAT LED TO POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, A COLONOSCOPY PERFORMED ON THE PATIENT REVEALED AN ADENOMATOUS NEOPLASM OF THE RIGHT COLON. AFTER A FULL DISCUSSION OF ALTERNATIVE, INDICATIONS, RISKS, AND COMPLICATIONS, THE PATIENT WISHED TO UNDERGO AN ONCOLOGIC RESECTION BECAUSE OF THE RISK AND/OR FUTURE RISK OF INVASIVE COLON CANCER, AND INFORMED CONSENT WAS OBTAINED. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE DA VINCI SI SURGICAL PROCEDURE WENT WELL. ON POST-OP DAY 1, THE PATIENT'S TEMPERATURE SPIKED TO 103 ALTHOUGH HER HEART RATE AND BLOOD PRESSURE WERE NORMAL, AND HER URINE OUTPUT WAS 1500 CC OVER THE PREVIOUS 12 HOURS. THE PATIENT HAD NO COMPLAINTS OF ABDOMINAL PAIN, ALTHOUGH THE ABDOMEN WAS NOTED TO BE A LITTLE DISTENDED. ON POST-OP DAY 3, THE PATIENT'S TEMPERATURE SPIKED AGAIN TO 101.7. SHE WAS NOT TACHYCARDIC AT THE TIME AND HER WHITE BLOOD CELL COUNT WAS NORMAL. UPON PHYSICAL EXAMINATION, NO SIGNS OF PERITONITIS WERE FOUND. A CHEST X-RAY AND ABDOMINAL FILMS SHOWED A MODERATE AMOUNT OF FREE AIR WITH A DILATED TRANSVERSE COLON AND AN AIR-FLUID LEVEL IN THE STOMACH. ON POST-OP DAY 3, THE PATIENT DEVELOPED SYMPTOMS OF TACHYCARDIA AND THE SURGEON INDICATED THAT HE BECAME CONCERNED ABOUT AN INTERNAL ABDOMINAL PROCESS. ON POST-OP DAY 4, THE PATIENT'S URINE OUTPUT BEGAN TO DECREASE AND HER CREATININE INCREASED FROM 1.1 TO 1.8. AFTER OBTAINING INFORMED CONSENT FROM THE PATIENT, THE SURGEON PERFORMED A LAPAROTOMY AND FOUND THAT THE LATERAL ASPECT OF THE COLON SIDE OF THE ANASTOMOSIS HAD INFARCTED AND THERE WAS A STAPLE LINE LEAK. IN ADDITION, THE SURGEON FOUND FECAL PERITONITIS. THE SURGEON PERFORMED RESECTION OF THE ILEOCOLIC ANASTOMOSIS, HARTMANN CLOSURE OF THE TRANSVERSE COLON, AND AN END ILEOSTOMY. IN ADDITION, THE SURGEON PLACED AN INTRAOPERATIVE WOUND VAC. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE SURGEON INDICATED THAT THE PATIENT BECAME SEPTIC REQUIRING SEDATION, PARALYSIS, CHEMICAL VENTILATOR, PRESSORS, AND BROAD-SPECTRUM ANTIBIOTICS. THE PATIENT'S ILEOSTOMY ALSO BECAME ISCHEMIC, BUT ULTIMATELY SURVIVED. MULTIPLE CHEST X-RAYS WERE PERFORMED POST-OPERATIVELY DUE TO RESPIRATORY FAILURE. IN ADDITION, MULTIPLE ABDOMINAL X-RAYS WERE PERFORMED POST-OPERATIVELY. THE PATIENT WAS DISCHARGED TO ANOTHER HOSPITAL ON (B)(6) 2011. AT THE TIME OF DISCHARGE, THE PATIENT WAS NOT FEBRILE OR TACHYCARDIC. HER URINE, STOMA FUNCTION, AND LABS WERE NOTED AS BEING EXCELLENT. THE SURGEON INDICATED THAT HE HAD DEBRIDED THE PATIENT'S OPEN WOUND WHICH HE NOTED AS LOOKING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE FROM THE HOSPITAL ON (B)(6) 2011." }, { "mdr_text_key": "11282725", "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 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. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED AN ANASTOMOSIS LEAK AND DEVELOPED PERITONITIS AND SEPSIS AFTER UNDERGOING A DA VINCI SI 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": "" } ] }