{ "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": "2955842-2015-00938", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20150625", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150519", "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": "20150626", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "413118", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150625", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20150625", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Emphysema", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20150528", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4869823", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150528", "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": "6044002", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD TO GO BACK TO THE OR AFTER A BOWEL LEAK WAS FOUND. ACCORDING TO THE INITIAL REPORTER, THE BOWEL LEAK WAS NOT IDENTIFIED DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. INTRA-OPERATIVELY, THE PATIENT EXPERIENCED SUBQ EMPHYSEMA WHICH THE SURGEON ATTRIBUTED TO A FASCIAL DEFECT THAT WAS CAUSED BY MULTIPLE PORTS BEING TAKEN IN AND OUT DURING THE SURGICAL PROCEDURE. THE PATIENT REPORTEDLY HAD BUBBLING AROUND THE FACE, EYES, FINGERS, AND HANDS. AS A RESULT OF THE EVENT, THE SITE HAS SINCE IMPLEMENTED A PROTOCOL TO MINIMIZE THE CHANCES OF THE SUBQ EMPHYSEMA OCCURRING IN FUTURE CASES. THE INITIAL REPORTER INDICATED THAT THE DA VINCI VENTRAL HERNIA REPAIR PROCEDURE WAS COMPLETED AND THE PATIENT INITIALLY DID WELL POST-OPERATIVELY. DURING THE SURGERY, THE SURGEON INSPECTED THE BOWEL AND DID NOT FIND ANY ISSUES. ON POST-OPERATIVE DAY 5, THE PATIENT REPORTEDLY CRASHED. THE PATIENT WAS BROUGHT BACK TO THE OR AND A SMALL BOWEL PERFORATION WAS FOUND. THE PATIENT'S ABDOMEN WAS IRRIGATED AND WASHED OUT. THE SURGEON THEN PERFORMED A BOWEL RESECTION. A DAY OR TWO LATER, THE PATIENT WAS BROUGHT BACK TO THE OR AND UNDERWENT FURTHER IRRIGATION AND CLEANSING OF THE ABDOMEN. FUNGUS WAS NOTED TO BE GROWING ON THE PATIENT'S ABDOMINAL WALL. ANTIBIOTICS WERE ADMINISTERED. PER THE INITIAL REPORTER, THE SURGEON PERFORMED A COMPLETE ABDOMINAL RESECTION. AT THIS TIME, THE PATIENT IS CURRENTLY STILL IN THE HOSPITAL AND IS RECOVERING. THE INITIAL REPORTER SPOKE TO THE SURGEON ABOUT THE POSSIBLE CAUSE OF THE BOWEL PERFORATION. THE SURGEON DID NOT DEFINITIVELY KNOW THE CAUSE OF THE BOWEL INJURY. HE INDICATED THAT HE DOES NOT BELIEVE AN ISSUE WITH THE DA VINCI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE BOWEL INJURY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON SUSPECTS THAT THE BOWEL INJURY POSSIBLY OCCURRED DURING TAKE-DOWN OF OMENTUM AND ADHESIONS AROUND THE HERNIA OR DURING REMOVAL OF OLD MESH THAT WAS FOLDED OVER. THE INITIAL REPORTER STATED THAT THE OLD MESH CAME FROM A PREVIOUS VENTRAL HERNIA REPAIR PROCEDURE THAT THE PATIENT HAD UNDERGONE IN THE PAST ON AN UNSPECIFIED DATE. THERE WAS NO MENTION THAT A DA VINCI SURGICAL SYSTEM WAS USED DURING THE PREVIOUS VENTRAL HERNIA REPAIR PROCEDURE." }, { "mdr_text_key": "13303722", "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 COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE ACTUAL CAUSE OF THE PATIENT'S OPERATIVE COMPLICATION IS 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": "" } ] }