{ "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": "2955842-2014-05344", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20140905", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120402", "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": "20140908", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "544139", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140905", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "KS", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20140905", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death", " H", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Tissue Damage", "Excessive Tear Production", "Injury", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20140808", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4065915", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141201", "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": "4858067", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE SURGEON SUSPECTED DURING THE DA VINCI SURGERY THAT HE HAD INJURED THE PATIENT'S BOWEL AND DECIDED TO CONVERT TO AN OPEN PROCEDURE. DURING THE OPEN PROCEDURE, THE SURGEON REPORTEDLY DISCOVERED A BOWEL PERFORATION (HOLE IN HER BOWELS). HE ALSO IDENTIFIED MULTIPLE TEARS IN THE MEMBRANE AROUND THE PATIENT'S BOWELS. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON BELIEVED THIS BOWEL DAMAGE WAS CAUSED BY A GRASPER ON THE DA VINCI ROBOT HE USED. AFTER IDENTIFYING THE BOWEL DAMAGE, THE SURGEON REMOVED PART OF THE PATIENT'S COLON AND THEN REPAIRED THE PATIENT'S HERNIA. THE LEGAL DOCUMENT CLAIMS THAT AFTER THE SURGERY WAS COMPLETED, THE PATIENT REMAINED HOSPITALIZED AND HER MEDICAL CONDITION DECLINED DUE TO COMPLICATIONS FROM THE BOWEL SURGERY. ON (B)(6) 2012 THE SURGEON DECIDED TO PERFORM AN EXPLORATORY SURGERY AFTER A BUILDUP OF GAS WAS OBSERVED IN THE PATIENT'S ABDOMEN. THE EXPLORATORY SURGERY REVEALED THAT THE PATIENT'S SMALL AND LARGE BOWEL WERE FOUND TO BE DEAD. THE PATIENT EXPIRED LATER THAT SAME DAY." }, { "mdr_text_key": "12608435", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT UNDERWENT A PLANNED ROBOTIC PARAESOPHAGEAL HERNIA REPAIR ON (B)(6) 2012 FOR AN INCARCERATED GIANT PARAESOPHAGEAL HERNIA. FOLLOWING TROCAR INSERTION AND DOCKING OF THE ROBOT, THE SURGEON STARTED REDUCING THE TYPE IV HERNIA WHICH CONTAINED SMALL BOWEL, COLON, STOMACH AND OMENTUM. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED, I STARTED TO PULL ON THE OMENTUM AND DELIVERED THE GREATER OMENTUM BACK IN THE PERITONEAL CAVITY. I STARTED TO RETRIEVE THE COLON AND THE STOMACH, AND I NOTICED A SMALL TEAR IN THE GASTRIC WALL AND THEN I WAS INFORMED BY THE ROBOTIC TEAM LEADER THAT THE SCRUB TECHNICIAN HAD INSERTED A PROGRASP INSTEAD OF THE CADIERE GRASPERS THAT I ASKED FOR. IT IS MY STANDARD TO PERFORM THIS PROCEDURE, ALL OF THEM, WITH THE CADIERE GRASPERS AS THEY ARE VERY GENTLE ON THE BOWEL AND THE ABDOMINAL VISCERA AND HAVING THE PROGRASP'S TOUGH GRIP (WHICH IS AT LEAST 4 TIME GREATER THAN THE CADIERE), I WAS ALARMED THAT BOWEL INJURY MIGHT HAVE OCCURRED. THE SURGERY WAS SUBSEQUENTLY CONVERTED TO AN OPEN PROCEDURE. THE SURGEON ALSO NOTED, ...TO QUESTION THE COLON AND THE SMALL BOWEL FROM THE PROGRASP DRIP [SIC]...I WAS CORRECT IN MY SUSPICION AS THERE WAS A SMALL COLON PERFORATION DUE TO THE GRASPER AND MULTIPLE TEARS TO THE SEROSA. THE SMALL BOWEL APPEARED INTACT AND HEALTHY. THE STOMACH GASTRIC PERFORATION WAS IDENTIFIED. APPROXIMATELY TWO INCHES OF THE TRANSVERSE COLON WAS RESECTED AND THE GASTRIC PERFORATION REPAIRED. THE SURGERY CONTINUED, WITH REPAIR OF THE HIATAL HERNIA WITH FLEXHD MESH, GASTROPEXY, OPEN REPAIR OF UMBILICAL HERNIA AND PROXIMAL LOOP COLOSTOMY. NO FURTHER OPERATIVE COMPLICATIONS WERE NOTED. THE ESTIMATED BLOOD LOSS WAS NOT PROVIDED. POST-OPERATIVELY, THE PATIENT WAS IN CRITICAL CONDITION IN THE SICU. SHE EXPERIENCED PROGRESSIVE RESPIRATORY FAILURE AND WAS EMERGENTLY INTUBATED. ON (B)(6) 2012, THE PATIENT UNDERWENT BRONCHOSCOPY, REMOVAL OF A BLOODY MUCOUS PLUG IN THE RIGHT MIDDLE LOBE OF THE LUNG, AND LEFT THORACOSTOMY TUBE PLACEMENT. ON (B)(6) 2012, THE PATIENT UNDERWENT PLACEMENT OF AN ADDITIONAL LEFT THORACOSTOMY TUBE, WITH AN INITIAL COLLECTION OF 2,000 ML OF FLUID. POST-OPERATIVE DIAGNOSIS INCLUDED RESPIRATORY FAILURE, LEFT PLEURAL EFFUSION AND POSSIBLE PNEUMOTHORAX. ON (B)(6) 2012, THE PATIENT UNDERWENT ULTRASOUND-GUIDED RIGHT PLEURAL DRAIN PLACEMENT WITH APPROXIMATELY 300 ML OF FLUID ASPIRATED. A LEFT-SIDED DRAIN WAS ATTEMPTED TO BE PLACED; HOWEVER, NO FLUID WAS RETURNED AND THE DRAIN WAS REMOVED. ON (B)(6) 2012, THE PATIENT'S INDWELLING RIGHT PLEURAL DRAINAGE CATHETER WAS INITIALLY UPSIZED AND REPLACED. THIS WAS SUBSEQUENTLY REMOVED, HOWEVER, FOLLOWING ULTRASOUND-GUIDED PLACEMENT OF A RIGHT THORACIC DRAINAGE CATHETER. ON (B)(6) 2012, THE PATIENT UNDERWENT BRONCHOSCOPY-ASSISTED PERCUTANEOUS TRACHEOSTOMY TUBE PLACEMENT DUE TO CONTINUING RESPIRATORY FAILURE AND VENTILATOR DEPENDENCE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR AN EXPLORATORY LAPAROTOMY. UPON ENTERING THE ABDOMEN, THE SMALL BOWEL AND THE LARGE BOWEL COULD NOT BE IDENTIFIED, AS THEY WERE NECROTIC. THE DECISION WAS MADE TO CLOSE THE PATIENT UP, AND SHE WAS TRANSFERRED BACK TO THE ICU. PALLIATIVE CARE WAS CONSULTED, AND THE PATIENT WAS SUBSEQUENTLY PRONOUNCED DEAD ON (B)(6) 2012 AT 22:36. DISCHARGE DIAGNOSES INCLUDED RESPIRATORY FAILURE, ACIDOSIS, ACUTE RENAL FAILURE, ANEMIA ASSOCIATED WITH ACUTE BLOOD LOSS, HYPOTENSION, SEPTIC SHOCK, DEATH - NECROTIC BOWEL. THE PATIENT HAD BEEN HOSPITALIZED FROM (B)(6) 2012. PER THE DEATH CERTIFICATE, THE CAUSE OF DEATH WAS MULTI-ORGAN FAILURE RESULTING FROM SEPSIS. THE DATE OF INJURY WAS NOTED AS (B)(6) 2012, WITH THE INJURY DUE TO SURGERY. AN AUTOPSY WAS NOT PERFORMED. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT PASSED AWAY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUSTAINING AN INTRA-OPERATIVE INJURY. HOWEVER, THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "12226527", "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 INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HER SUBSEQUENT DEMISE. 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. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2012. AT ONE POINT DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED SYSTEM ERROR CODE 23005. AN ERROR CODE 23005 IS A RECOVERABLE FAULT THAT OCCURS WHEN THE SERVO SYSTEM DETECTS A CONDITION WHERE IT WAS GENERATING AN UNEXPECTEDLY HIGH AMOUNT OF OUTPUT POWER. IN THIS CASE, THE OUTPUT POWER WAS DETECTED TO BE TOO HIGH ON PATIENT SIDE MANIPULATOR (PSM) 3. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. AN ERROR CODE 23005 CAN ALSO OCCUR WHEN PSMS COLLIDE WITH ONE ANOTHER OR SOMETHING ELSE IN THE ENVIRONMENT. WHEN NO COLLISIONS AND/OR RAPID MOVEMENT WERE INVOLVED, THE ERROR CODE 23005 MAY REPRESENT AN ENCODER FAILURE. ALSO, ACCORDING TO THE SITE'S SYSTEM LOGS, A PROGRASP FORCEPS INSTRUMENT (PART 420093; LOT M10120123-333) WAS USED DURING THE REPORTED SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THAT THE INSTRUMENT WAS USED IN 9 SUBSEQUENT DA VINCI SURGICAL PROCEDURES AND NO COMPLAINTS REGARDING THE INSTRUMENT WERE REPORTED TO ISI. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT EXPERIENCED INTRA-OPERATIVE COMPLICATIONS WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE AND SUBSEQUENTLY PASSED AWAY. HOWEVER, AT THIS TIME, THE CAUSES OF THE PATIENT'S INTRA-OPERATIVE COMPLICATIONS AND SUBSEQUENT DEMISE ARE UNKNOWN." } ], "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": "12/29/2014" } ] }