{ "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": "2955842-2014-05536", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20141023", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140917", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20141024", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "675493", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20141023", "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": [ "Torn Material" ], "reporter_state_code": "MS", "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": "20141023", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "60 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Perforation", "Sepsis" ] } ], "distributor_city": "", "date_report": "20140923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4197885", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140923", "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": "18940155", "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. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI NISSEN FUNDOPLICATION PROCEDURE, THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS DUE TO A SUTURE TEAR IN THE STOMACH. THERE WAS NO ALLEGATION BY THE HOSPITAL, THAT THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE." }, { "mdr_text_key": "18539589", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT 2 DAYS POST A SUCCESSFUL COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ABDOMINAL PAIN, REQUIRING THE PATIENT TO UNDERGO AN OPEN SURGICAL PROCEDURE. DURING THE OPEN PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT WAS LEAKING FROM THE STOMACH, CAUSING THE PATIENT TO BECOME SEPTIC. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S ROBOTICS COORDINATOR (RC). ACCORDING TO THE RC, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE RC INDICATED THAT THE PATIENT UNDERWENT THE PLANNED DA VINCI SURGICAL PROCEDURE ON SEPTEMBER 17, 2014 AND WAS DISCHARGED FROM THE HOSPITAL ON SEPTEMBER 18, 2014. ON SEPTEMBER 19, 2014, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM. AN ENDOSCOPIC PROCEDURE PERFORMED ON THE PATIENT REVEALED THAT THERE WAS A HOLE IN THE PATIENT'S STOMACH AND THAT STOMACH CONTENTS HAD SPILLED OUT ONTO THE PATIENT'S PERITONEUM. AS A RESULT THE PATIENT DEVELOPED SEPSIS. ACCORDING TO THE RC, THE PATIENT CODED DURING THE PATIENT'S EMERGENCY HOSPITALIZATION; HOWEVER, THE PATIENT WAS SUCCESSFULLY RESUSCITATED. THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE TO REPAIR THE DEFECT AND THE PATIENT WAS RECOVERING IN THE INTENSIVE CARE UNIT. THE RC INDICATED THAT THE TEAR IN THE PATIENT'S STOMACH WAS LOCATED WHERE A SUTURE HAD BEEN PLACED. THE SURGEON DOES NOT KNOW WHAT CAUSED THE SUTURE TEAR AS HE INDICATED THAT HE HAD NEVER SEEN THIS TYPE OF INCIDENT. ACCORDING TO THE RC, THERE WAS NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE AND THERE IS NO ALLEGATION BY THE SURGEON OR THE HOSPITAL THAT THE DA VINCI SYSTEM, INSTRUMENTS AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO TEAR IN THE PATIENT STOMACH. THE RC INDICATED THAT IT IS UNKNOWN WHAT CAUSED THE POST-SURGICAL COMPLICATION EXPERIENCED BY THE PATIENT. ACCORDING TO THE RC, IT IS UNKNOWN IF THE STITCH WAS PLACED TOO TIGHT OR TISSUE DEGRADATION CAUSED THE ISSUE. THERE IS NO VIDEO RECORDING OF THE ROBOTIC PROCEDURE. ON (B)(4) 2014, ISI RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S STATUS FROM THE HOSPITAL'S RC. ACCORDING TO THE RC, THE PATIENT RECOVERED WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL. SHE DOES NOT KNOW THE DATE THAT THE PATIENT WAS DISCHARGED AND WAS UNABLE TO PROVIDE ANY OTHER INFORMATION REGARDING THE REPORTED EVENT." } ], "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": "" } ] }