{ "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": "I", "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": "2955842-2019-10654", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190822", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20130404", "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": "US", "manufacturer_contact_area_code": "", "date_added": "20190822", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "713163", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190822", "brand_name": "DA VINCI SI SURGICAL SYSTEM", "generic_name": "N/A", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "N/A", "catalog_number": "N/A", "lot_number": "N/A", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/05/2021", "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": "20190822", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Obstruction/Occlusion", "Adhesion(s)", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20190731", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8923212", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190731", "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": "325927860", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "325927861", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "REFER TO THE FOLLOWING FIELDS FOR CORRECTED INFORMATION: D2A, D2B, D4. REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: G3, G6, H2, AND H10. THE PRODUCT INFORMATION IN FIELDS D2A, D2B, AND D4 HAS BEEN UPDATED." }, { "mdr_text_key": "159836212", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4) - BASED ON THE INFORMATION PROVIDED, THE PATIENT IS NOT CLAIMING THAT THE ROBOTIC EQUIPMENT WAS FAULTY. HOWEVER, SHE BELIEVES THAT POSSIBLY INADEQUATE TRAINING OR SUPERVISION OF THE INTERN WITH THE DA VINCI SURGICAL SYSTEM WAS A CONTRIBUTING FACTOR IN REGARDS TO THE OPERATIVE COMPLICATION THAT SHE EXPERIENCED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT EXPERIENCED A BOWEL OBSTRUCTION SECONDARY TO AN INCARCERATED HERNIA. AS A RESULT, SHE HAD A SECOND PROCEDURE TO RESOLVE THE ISSUE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ." }, { "mdr_text_key": "159836213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 31ST ¿ JULY-2019, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT # MW5088146 WITH THE FOLLOWING EVENT DESCRIPTION: ¿I WENT IN FOR WHAT WAS SUPPOSED TO BE AN UNCOMPLICATED DAVINCI LAPAROSCOPIC PROCEDURE TO REMOVE AN OVARIAN CYST, INSTEAD, I HAD MY ENTIRE OVARY REMOVED, AND DUE TO THE COMPLICATIONS THAT OCCURRED DURING THIS SURGERY RESULTED IN AN ER VISIT. TWO ADD¿L HOSPITALIZATIONS AND SUBSEQUENT SURGERY TO CORRECT THE COMPLICATION OF INCARCERATED HERNIA CAUSED BY PART OF MY INTESTINE BEING PULLED OUT OF THE ROBOTIC INSTRUMENT WHICH WAS SUBSEQUENTLY STITCHED BY THE SURGICAL INTERN CAUSING COMPLETE BLOCKAGE OF MY INTESTINE, THIS COMPLICATION WOULD HAVE BEEN FATAL IF NOT CAUGHT BY A DIFFERENT PHYSICIAN. THIS COMPLICATION WAS DUE TO INADEQUATE TRAINING OR SUPERVISION BY THE ATTENDING SURGEON, WHO LEFT THE ROOM AND DID NOT INSTRUCT HIS INTERN ON TO HOW TO AVOID THIS POTENTIAL COMPLICATION THAT CAN OFTEN HAPPEN WITH DAVINCI SURGERIES IF CERTAIN STEPS ARE NOT FOLLOWED BY THE SURGEON TO PREVENT THEM. I AM VERY LUCKY THAT A DOCTOR FINALLY LISTENED TO ME AFTER A WEEK IN THE HOSPITAL AND THE INCARCERATED HERNIA CAUSED BY THIS DA VINCI SURGERY WAS REPAIRED A WEEK LATE, IF THAT HAD NOT BEEN THE CASE, I WOULD MOST CERTAINLY HAD EXPERIENCED A BOWEL PERFORATION. LIKELY RESULTING IN SEPSIS OR DEATH.¿ ON 21-AUGUST-2019, ISI FOLLOWED UP WITH THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT REPORTED THAT SHE UNDERWENT A DA VINCI ASSISTED SURGICAL PROCEDURE TO REMOVE AN OVARIAN CYST. HOWEVER, THE SURGERY ENDED UP AS AN OOPHORECTOMY, AND AN ENDOMETRIAL RESECTION WITH ADHESION REMOVAL. SHE REPORTED THAT AT THE TAIL END OF THE PROCEDURE, THE CONSOLE SURGEON LEFT THE ROOM FOR THE RESIDENT TO SUTURE THE INCISION. THAT SAME DAY SHE WAS SCHEDULED TO BE DISCHARGED; HOWEVER, SHE STARTED FEELING SICK AND HAD TROUBLE URINATING. AS A RESULT, A STRAIGHT CATHETER WAS PLACED AND THERE WERE ALMOST 2.5 LITERS OF URINE OUTPUT. SHE STATED SHE HAD A DIFFICULT TIME TO CONVINCE THE HOSPITAL THAT SHE WAS STRUGGLING WITH PAIN. THE NEXT DAY SHE WAS DISCHARGED. ON APPROXIMATELY POST-OPERATIVE DAY #2, SHE WENT BACK TO THE ER WITH SEVERE VOMITING AND DISCOMFORT. THE SITE DID NOT PERFORM ANY DIAGNOSTIC TEST FOR A COUPLE OF DAYS. ON APPROXIMATELY POST-OPERATIVE DAY # 5 OR 6, SHE HAD A CT SCAN, AND AN NG TUBE WAS INSERTED. THE NG TUBE DRAIN WAS FILLED WITH GREEN FLUID. THE CT SCAN RESULTS INDICATED A BOWEL OBSTRUCTION. AS A RESULT, SHE HAD SURGERY THE SAME DAY. SHE DOES NOT RECALL THE NAME OF THE SURGEON OR IF IT WAS A DAVINCI PROCEDURE. IN THE SECOND PROCEDURE, THE SURGEON IDENTIFIED AN INCARCERATED HERNIA. THE BOWEL WAS PULLED ALONG AND SUTURED WITH THE INCISION, WHICH LED TO THE BOWEL OBSTRUCTION. THE SURGEON WHO CONDUCTED THE SECOND PROCEDURE STATED THAT IT WAS SURGEON NEGLIGENCE IN THE FIRST PROCEDURE. THE CONSOLE SURGEON DID NOT INSTRUCT THE INTERN ON HOW TO COMPLETE THE FINAL STEPS IN A DAVINCI PROCEDURE TO AVOID THIS KIND OF COMPLICATION. SHE REPORTEDLY HAD A COUPLE OF OTHER MEDICAL OPINIONS CONFIRMING THAT THE SURGICAL COMPLICATION SHE EXPERIENCED WAS SOLELY SURGEON ERROR. THE PATIENT CONFIRMED THAT THERE WAS NO ALLEGATION THAT A DAVINCI SYSTEM OR DEVICE MALFUNCTIONED IN A WAY THAT CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS SHE EXPERIENCED." } ], "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": "07/31/2021" } ] }