{ "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": "Death", "report_number": "2955842-2013-04566", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131023", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20090722", "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": "20131024", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "544304", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131023", "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, A5.1P8", "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": "FL", "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": "20131023", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Death", "Laceration(s)", "Urinary Retention", "Hernia", "Discomfort", "Blood Loss", "Device Embedded In Tissue or Plaque", "No Code Available" ] } ], "distributor_city": "", "date_report": "20130923", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3425893", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130923", "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": "3944348", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT DIED ON (B)(6) 2013 DUE TO A RETAINED FOREIGN BODY LEFT INSIDE THE PATIENT DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PARAESOPHAGEAL HERNIA AND WAS DISCHARGED ON (B)(6) 2009. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION FOR HIS LARGE PARAESOPHAGEAL HERNIA WITH HIATAL HERNIA AND GASTROESOPHAGEAL REFLUX DISEASE. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2009, THE PATIENT'S CT SCAN OF HIS ABDOMEN REVEALED A GAS FILLED STOMACH AND LOOPS OF LARGE AS WELL AS SMALL BOWEL SUGGESTING POSTOPERATIVE ILEUS AND GAS WAS SEEN IN RECTUM. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT DID WELL POSTOPERATIVELY. HE UNDERWENT A SWALLOW STUDY, WHICH WAS FOUND TO BE WITHIN NORMAL LIMITS, THE PATIENT STARTED COMPLAINING OF SOME LEFT-SIDED DISCOMFORT AND WAS NOT GIVEN ANYTHING BY MOUTH. HIS DIET SLOWLY ADVANCED AFTER PAIN WAS IMPROVED. THE PATIENT ALSO HAD ISSUES WITH URINARY RETENTION AND A FOLEY CATHETER WAS PLACED. THE PATIENT TOLERATED HIS FEEDS WELL AND HIS PAIN MANAGEMENT WAS APPROPRIATE. THE PATIENT WAS TO SET UP WITH HOME HEALTH TO ASSIST IN HIS CARE AND DISCHARGED ON (B)(6) 2009. BASED ON THE PROVIDED MEDICAL RECORDS, THE PATIENT SOUGHT AND RECEIVED MEDICAL TREATMENT FROM (B)(6) 2009 THROUGH (B)(6) 2013 FOR ABDOMINAL PAIN, TESTICULAR PAIN, NEUROGENIC BLADDER, URINARY TRACT INFECTION, DYSPHAGIA, DYSURIA, FOLEY CATHETER ISSUES, SUPRAPUBIC CATHETER PLACEMENT, PHARYNESOPHAGEAL PHASE DYSPHAGIA, INCARCERATED RIGHT INGUINAL HERNIA REPAIR, PARAESOPHAGEAL HIATAL HERNIA REPAIR, AND NISSEN FUNDOPLICATION REPAIR. ON (B)(6) 2009, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR AN INCARCERATED RIGHT INGUINAL HERNIA BY PRIMARY SUTURE WHICH REQUIRED OPEN REDUCTION AND REPAIR. ACCORDING TO ONE OF THE MEDICAL RECORDS, THE PATIENT HAD AN EPISODE OF FOOD POISONING AFTER EATING AT A RESTAURANT ON AN UNSPECIFIED DATE. HE WENT TO THE EMERGENCY ROOM AND HIS CT SCAN REVEALED SOMETHING THAT APPEARED TO BE A FOREIGN BODY WRAPPED AROUND THE STOMACH. THE CT SCAN RESULTS WERE NOT PROVIDED. ON (B)(6) 2012 (APPROXIMATELY 2 YEARS AFTER THE DA VINCI SURGERY), THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EVALUATE THE POSSIBLE INTRAABDOMINAL FOREIGN BODY AND TO EVALUATE THE NISSEN FUNDOPLICATION. PER THE OPERATIVE REPORT, THERE WAS A SLIPPAGE OF THE NISSEN FUNDOPLICATION, THE STOMACH HAD SLIPPED DOWN AROUND AND WAS LIKELY CAUSING DIFFICULTY WITH DYSPHAGIA. THE OPERATIVE REPORT ALSO NOTED THAT A FOREIGN BODY THAT APPEARED TO BE RADIODENSE WAS WRAPPED AROUND THE STOMACH SOMEWHAT LIKE WHAT WOULD BE SEEN IN A LAP-BAND; HOWEVER, THERE WAS NO FOREIGN BODY FOUND. ON (B)(6) 2013, THE PATIENT WAS DIAGNOSED WITH A FOREIGN BODY AROUND THE AREA OF THE ESOPHAGUS. ON (B)(6) 2013, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR HIS RECURRENT HIATAL HERNIA AND ESOPHAGEAL STRICTURE AND SECOND ATTEMPT WAS MADE TO LOCATE THE FOREIGN BODY. THE OPERATIVE REPORT INDICATED THAT THE PATIENT SUSTAINED A SIGNIFICANT BLOOD LOSS DURING THE EXPLORATION OF THE ABDOMEN AND THE FOREIGN BODY COULD NOT BE FOUND. THE PATIENT SUBSEQUENTLY BECAME ASYTOLIC AND WAS PRONOUNCED DEAD. UPON PRONOUNCING HIS DEATH, A LARGE DEFECT WAS FOUND IN THE PATIENT'S VENA CAVA POSTERIOR TO THE LIVER AT THE LEVEL OF THE DIAPHRAGM. THE PATIENT'S AUTOPSY REPORT INDICATED THAT THE PATIENT DIED FROM CARDIAC ARREST. THE AUTOPSY FINAL DIAGNOSIS NOTED THERE WAS A LONGITUDINAL TEAR ON THE INFERIOR VENA CAVA, SEVERE SURGICAL LACERATIONS ON THE LIVER, AND FINDINGS WITH THE HEART AND MEDIASTINUM ASSOCIATED WITH RESUSCITATION. A FOREIGN BODY, 0.5 CM CIRCUMFERENTIAL, COILED BAND, WAS IDENTIFIED ENCIRCLING THE GASTROESOPHAGEAL JUNCTION AND EMBEDDED IN TOUGH FIBROUS CONNECTIVE TISSUE OF THE ESOPHAGEAL WALL CONSISTENT WITH PREVIOUS SURGERY." }, { "mdr_text_key": "11445600", "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 AND DEATH EXPERIENCED BY THE PATIENT. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ISI ATTEMPTED TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE; HOWEVER, THE SITE WAS UNABLE TO PROVIDE ANY INFORMATION RELATED TO THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. BASED ON THE PROVIDED INFORMATION, THERE WAS NO EVIDENCE OF A MALFUNCTION RELATED TO THE DA VINCI SYSTEM, INSTRUMENTS, AND OR ACCESSORIES. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI S PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2009 AND SUBSEQUENTLY DIED ON (B)(6) 2013. THE PATIENT'S AUTOPSY CONFIRMED THERE WAS AN UNKNOWN FOREIGN BODY WAS IDENTIFIED AS AN 0.5 CM CIRCUMFERENTIAL, COILED BAND ENCIRCLING THE PATIENT'S GASTROESOPHAGEAL JUNCTION; HOWEVER, THE PATIENT'S CAUSE OF DEATH WAS NOTED TO BE CARDIAC ARREST." } ], "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": "" } ] }