{ "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": "2955842-2013-01556", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130506", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20100901", "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": "20130507", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "196353", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130506", "brand_name": "DA VINCI S 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": "IS2000 A51.P8", "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": "20250812", "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": "20130506", "sequence_number_treatment": [ "DA VINCI S SURG SYST., INSTRUMENTS AND ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "67 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Perforation of Esophagus" ] } ], "distributor_city": "", "date_report": "20120905", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3094953", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120905", "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": "3160817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2012, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHOM UNDERWENT A DA VINCI S NISSEN FUNDOPLICATION ON (B)(6) 2010 AT (B)(6), EXPERIENCED SEVERE ABDOMINAL PAIN. THE LEGAL COMPLAINT ALLEGES THAT ON (B)(6) 2010, THE PATIENT UNDERWENT EXPLORATORY LAPAROSCOPY AND ESOPHAGOGASTRODUODENOSCOPY PROCEDURES AND IT WAS DISCOVERED THAT THE PATIENT'S DISTAL ESOPHAGUS HAD A PERFORATION. ALLEGEDLY, THE PATIENT WAS TRANSFERRED TO THE UNIVERSITY OF IOWA HOSPITALS AND CLINICS FOR FURTHER MEDICAL MANAGEMENT. ALLEGEDLY, THE PATIENT UNDERWENT MULTIPLE SURGERIES TO REPAIR THE ESOPHAGEAL PERFORATION AND THE PATIENT REQUIRED AN EXTENDED COURSE OF TREATMENT DUE TO THE SEVERITY OF THE INJURY." }, { "mdr_text_key": "10880124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS MADE SEVERAL ATTEMPTS TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PATIENT'S OPERATIVE REPORT FOR THE DA VINCI S NISSEN FUNDOPLICATION PROCEDURE PERFORMED ON (B)(6) 2010 FOUND NO INDICATION THAT THE PATIENT EXPERIENCED ANY COMPLICATIONS DURING THE SURGICAL PROCEDURE AND THERE WAS NO INDICATION THAT ANY MALFUNCTION OF THE SITE'S DA VINCI S SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED. THE PATIENT'S OPERATIVE REPORT STATED THAT THE PATIENT COMPLAINED OF SIGNIFICANT REFLUX DISEASE, WHICH CAUSED LIMITATIONS IN THE PATIENT'S ROUTINE LIFESTYLE AND DUE TO THE PATIENT'S CONDITION, THE PATIENT WAS OFFERED THE ROBOTIC NISSEN FUNDOPLICATION PROCEDURE. THE OPERATIVE REPORT INDICATED THAT ALL RISKS, BENEFITS, AND ALTERNATIVES OF THE PROCEDURE WERE THOROUGHLY DISCUSSED WITH THE PATIENT PRIOR TO THE PATIENT'S AGREEMENT TO THE SURGERY. THE PATIENT'S CONSENT WAS OBTAINED PRIOR TO THE SURGICAL PROCEDURE. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S HERNIA SAC WAS TAKEN DOWN AND A LARGE HIATAL HERNIA DEFECT WAS APPRECIATED. THE PATIENT'S HERNIA SAC WAS COMPLETELY REDUCED AND EXCISED. THE REPORT INDICATED THAT INITIALLY THE PATIENT EXPERIENCED SOME BLEEDING ALONG THE UNDERSURFACE OF THE LIVER DUE TO A SLIGHT TEAR THAT OCCURRED AS A RESULT OF THE RETRACTION OF THE PATIENT'S LIVER. THE BLEEDING WAS CONTROLLED WITH THE APPLICATION OF PRESSURE AND SURGICEL. IT WAS INDICATED THAT THE SURGEON PROCEEDED TO WRAP THE GREATER CURVE OF THE PATIENT'S STOMACH AROUND THE POSTERIOR ASPECT OF THE GE JUNCTION AND THEN REPAIRED THE PATIENT'S HERNIA DEFECT USING INTERRUPTED 2-0 SILK SUTURES IN A FIGURE-OF-EIGHT FASHION TO RE-APPROXIMATE THE PATIENT'S CRUS MUSCLES. TWO POSTERIOR AND ONE ANTERIOR TO THE PATIENT'S ESOPHAGUS WERE PLACED. IT WAS INDICATED THAT A LOOSE WRAP WAS APPRECIATED AND THE SURGEON SECURED THE WRAP WITH INTERRUPTED 2-0 SILK SUTURES AND AFTER COMPLETION OF THE WRAP, HIS REEXAMINATION OF THE SURGICAL FIELD FOUND THAT ALL OF THE SUTURES APPEARED TO BE STABLE. PER THE INFORMATION INDICATED IN THE PATIENT'S OPERATIVE REPORT, THE PATIENT AWOKE FROM ANESTHESIA AND WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. ISI'S REVIEW OF THE SITE'S SYSTEM LOGS FOR PROCEDURES PERFORMED ON THE REPORTED PROCEDURE DATE FOUND THAT THERE WERE NO OCCURRENCES OF ANY SYSTEM ERRORS DURING ANY OF THE PROCEDURES PERFORMED THAT CAUSED OR CONTRIBUTED TO THE ALLEGED INJURY SUSTAINED BY THE PATIENT." } ], "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": "" } ] }