{ "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": "2955842-2014-01026", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "", "date_received": "20140220", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140103", "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", "COMPANY REPRESENTATIVE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20140221", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "107293", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140220", "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": "DA", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;10/31/2017", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20140220", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " R" ], "patient_age": "72 YR", "patient_sex": "", "patient_weight": "95", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20140123", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3638227", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140422", "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": "11788326", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2014 AND (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SITE'S RISK MANAGEMENT DEPARTMENT. ACCORDING TO THE RISK MANAGER, THE PATIENT'S MEDICAL DIAGNOSIS CONSISTED OF A LARGE HIATAL HERNIA WITH INCARCERATED OR VOLVULIZED STOMACH, HYPOTHYROIDISM, NARCOTIC DEPENDENCE, DEPRESSION, HISTORY OF COPD, AND HISTORY OF BARRETTS ESOPHAGUS. THE DA VINCI NISSEN FUNDOPLICATION PROCEDURE WAS NOT RECORDED. THE LENGTH OF THE SURGICAL PROCEDURE WAS APPROXIMATELY 6 HOURS. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE ALSO NO REPORTS THAT AN INTRA-OPERATIVE COMPLICATION OCCURRED DURING THE PROCEDURE. ON POST-OPERATIVE DAY 3, THE PATIENT WAS READMITTED TO THE ICU WITH COMPLAINTS OF INCREASING PAIN. THE PATIENT'S CREATININE LEVEL AND WHITE COUNT BEGAN TO RISE. A CT SCAN REVEALED A LARGE AMOUNT OF FREE AIR AND PROBABLE EXTRAVASATION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND A LOCALIZED PERFORATION WAS FOUND AT THE LEFT POSTERIOR LATERAL WALL FUNDUS. THE PATIENT HAD DEVELOPED BILATERAL EFFUSIONS, CANDIDEMIA, AND A WOUND INFECTION WITH CANDIDA. ACCORDING TO THE SURGEON, THE PATIENT'S CAUSE OF DEATH WAS DUE TO THE FOLLOWING: LARGE HIATAL HERNIA WITH INCARCERATED VOLVULIZED STOMACH, CHRONIC CHOLECYSTITIS AND CHOLELITHIASIS, OBESITY, DEPRESSION, HISTORY OF BARRETTS ESOPHAGUS, HISTORY OF COPD, EPIGASTRIC HERNIA. ACCORDING TO THE RISK MANAGER, THE PATIENT PASSED AWAY ON (B)(6) 2014. SHE DID NOT KNOW IF THE PATIENT'S DEATH CERTIFICATE WAS AVAILABLE. THE RISK MANAGER WAS UNABLE TO PROVIDE THE CAUSE OF THE LOCALIZED GASTRIC PERFORATION. SHE ALSO DID NOT KNOW IF THE GASTRIC PERFORATION WAS A CONTRIBUTING FACTOR TO THE PATIENT'S DEMISE." }, { "mdr_text_key": "11632293", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED. 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) 2014. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATED STOMACH AND SUBSEQUENTLY PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S INJURY AND SUBSEQUENT DEMISE ARE UNKNOWN." }, { "mdr_text_key": "4179579", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND PARA-ESOPHAGEAL REPAIR PROCEDURE, THE PATIENT RETURNED TO THE ICU ON POST-OPERATIVE DAY 3. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS OBSERVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 3 AND A PERFORATION OF HER STOMACH WAS FOUND. THE INJURY WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 8 DAYS LATER. THE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT PASSED AWAY. THE INITIAL REPORTER DID NOT KNOW THE CAUSE OF THE PATIENT'S DEMISE. HE STATED THAT THE PATIENT HAD COMPROMISED HEALTH PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER." }, { "mdr_text_key": "106165722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "NOTE: THE INFORMATION PROVIDED BELOW WAS ORIGINALLY SUBMITTED TO THE FDA ON 04/03/2015 VIA A SUPPLEMENTAL MDR (MFR REPORT 2955842-2015-00250). HOWEVER, AT THE TIME THE SUPPLEMENTAL MDR (MFR REPORT 2955842-2015-00250) WAS SUBMITTED, ISI WAS UNAWARE THAT THE REPORTED EVENT AND FOLLOW-UP INFORMATION HAD ALREADY BEEN SUBMITTED TO THE FDA ON 02/20/2014 AND 05/16/2014 RESPECTIVELY VIA MFR REPORT 2955842-2015-00250. AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NISSEN FUNDOPLICATION WITH REPAIR OF A HIATAL HERNIA AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2014 FOR A LARGE INCARCERATED HIATAL HERNIA WITH HISTORY OF BARRETT ESOPHAGUS, AND CHRONIC CHOLECYSTITIS AND CHOLELITHIASIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT, ADDITIONAL OPERATIVE REPORT, PROGRESS NOTES, AND AUTOPSY REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED IN THE DA VINCI SURGICAL PROCEDURE. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON NOTED THAT THE PATIENT WAS EXTUBATED AND TRANSFERRED TO RECOVERY ROOM WITH STABLE VITAL SIGNS. THE ESTIMATED BLOOD LOSS FOR THE PROCEDURE WAS 75 CC. ON (B)(6) 2014, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH REPAIR OF A GASTRIC PERFORATION AND ABDOMINAL WASHOUT. THE OPERATIVE REPORT INDICATES THAT PATIENT HAD BEEN TOLERATING LIQUIDS AND WAS AMBULATORY AND AFEBRILE POST-OPERATIVELY FROM THE DA VINCI SURGICAL PROCEDURE. HOWEVER, ON (B)(6) 2014, THE PATIENT BECAME OLIGURIC WITH INCREASING CREATININE AND CONFUSION. A CT-SCAN REVEALED A LARGE AMOUNT OF FREE AIR AND FLUID IN THE ABDOMEN. THE PATIENT ALSO UNDERWENT REPAIR OF A VENTRAL HERNIA AND INSERTION OF BILATERAL CHEST TUBES. ACCORDING TO THE OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED PERITONITIS SECONDARY TO A 1 CM PERFORATION OF THE UPPER FUNDUS AT THE LEFT POSTEROLATERAL WALL ON THE LATERAL ASPECT OF THE WRAP. THE SURGEON NOTED, I PRESUME THAT THIS PERFORATION WAS EITHER AN INJURY FROM A GRASPER OR PERHAPS THE HARMONIC SCALPEL IN MOBILIZING THE GREATER CURVATURE AND SHORT GASTRICS IN PREPARATION FOR THE WRAP. THE SURGEON WAS ABLE TO OVERSEW THE PERFORATION AND NO OTHER LEAKS WERE FOUND. ACCORDING TO THE PATIENT'S AUTOPSY REPORT, THE CAUSE OF DEATH WAS COMPLICATIONS OF BACTERIAL SEPSIS DUE TO ACUTE GRAM-POSITIVE COCCI BACTERIAL PERITONITIS AND ABSCESS FORMATION WITH POSSIBLE GRAM-NEGATIVE DIPLOCOCCIC BACTERIAL PERITONITIS AND INFECTIOUS COMPLICATIONS OF SURGICAL THERAPY FOR HIATAL HERNIORRHAPHY. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTROINTESTINAL PERFORATION AND SUBSEQUENTLY PASSED AWAY." } ], "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": "05/16/2014;11/09/2017" } ] }