{ "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": "2955842-2014-05307", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140828", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130716", "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": "20140829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "525368", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140828", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20140828", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "69", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Pneumonia", "Injury" ] } ], "distributor_city": "", "date_report": "20140801", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4045617", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140801", "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": "21731749", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: (B)(4) 2014: PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2013 FOR A PARTIAL HYSTERECTOMY. SURGERY WAS PERFORMED ON (B)(6) 2013. AFTER SURGERY PATIENT SHOULD HAVE AWAKENED AFTER APPROXIMATELY 3 HOURS. TEN HOURS FOLLOWING SURGERY PATIENT WAS PLACED IN ICU. DOCTORS EXPLAINED THAT MEDICATION CAUSED HER TO SLEEP LONGER. PATIENT WAS RELEASED FROM ICU THE FOLLOWING DAY. PATIENT NOTICED CLEAR LIQUID LEAKING FROM HER VAGINA AND SHE HAD TROUBLE BREATHING. SHE SAW DIFFERENT DOCTORS 3 TIMES AND THEN FINALLY WENT TO THE EMERGENCY ROOM. CT SCAN SHOWED SHE HAD PNEUMONIA AND WAS PLACED ON ANTIBIOTICS. FIVE DAYS LATER SHE STILL HAD LEAKING AND TROUBLE BREATHING SO SHE WENT TO A DIFFERENT EMERGENCY ROOM. CT SCAN SHOWED DURING THE ORIGINAL SURGERY THE DOCTOR CUT THE URETER. ONCOLOGIST RECOMMENDED THAT SHE CONTACT HER ORIGINAL SURGEON. SHE HAS APPREHENSIONS ABOUT IT BECAUSE HE MESSED UP THE ORIGINAL SURGERY. HER SURGERY IS SCHEDULED FOR NEXT MONTH. SHE HAS LOST HER JOB BECAUSE OF COMPLICATIONS FROM HER SURGERY. SHE HAS NO MEDICAL INSURANCE AND IS LOOKING INTO BRINGING SUIT. IT HAS BEEN ABOUT A YEAR AND SHE IS STILL EXPERIENCING PAIN. ON (B)(4) 2014, ISI CONTACTED THE PATIENT REGARDING THE REPORTED EVENT. ACCORDING TO THE PATIENT, SHE UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 AND WAS RELEASED FROM THE HOSPITAL'S INTENSIVE CARE UNIT (ICU) ON (B)(6) 2013. ACCORDING TO THE PATIENT, POST-OPERATIVELY SHE EXPERIENCED RIGHT SIDE TORSO PAIN AND VAGINAL LEAKAGE. ON (B)(6) 2013 SHE PRESENTED TO THE HOSPITAL'S EMERGENCY ROOM (ER) WITH SYMPTOMS OF SHORTNESS OF BREATH AND VAGINAL LEAKAGE. A CT SCAN PERFORMED FOUND THAT SHE HAD PNEUMONIA; HOWEVER, THE DAMAGE TO HER URETER WAS NOT IDENTIFIED DURING HER ER HOSPITALIZATION. SHE WAS PRESCRIBED ANTIBIOTICS TO TREAT HER PNEUMONIA. ACCORDING TO THE PATIENT, DURING THE HER POST-OPERATIVE FOLLOW UP VISIT ON AN UNSPECIFIED DATE IT WAS DISCOVERED THAT SHE HAD VAGINAL DISCHARGE AND SHE WAS PRESCRIBED AN ANTIBIOTIC TO TREAT HER CONDITION. ACCORDING TO THE PATIENT, ON (B)(6) 2013, SHE PRESENTED TO THE ER OF ANOTHER AREA HOSPITAL COMPLAINING OF PAIN AND VAGINAL LEAKAGE. IT WAS DISCOVERED THAT HER URETER HAD BEEN CUT. SHE UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE DEFECT; HOWEVER, THE DATE THAT THE SHE UNDERWENT THE PROCEDURE WAS NOT PROVIDED. ON (B)(4) 2014, ISI CONTACTED THE SURGEON WHO PERFORMED THE INITIAL SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY WITH SALPINGECTOMY PROCEDURE DUE TO MULTIPLE FIBROIDS, HEAVING BLEEDING AND ANEMIA. THE SURGEON INDICATED THAT THE PATIENT HAD A DIFFICULT ANATOMY DUE TO MULTIPLE LARGE FIBROIDS AND SIGNIFICANT ADHESIONS FROM PREVIOUS PELVIC SURGERY. THE PATIENT WAS TRANSFUSED WITH 1 UNIT OF BLOOD. ACCORDING TO THE SURGEON, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 FOR A POST-SURGICAL FOLLOW UP VISIT. DURING THE FOLLOW-UP VISIT, THE PATIENT WAS FOUND TO BE RECOVERING WELL. THE SURGEON INDICATED ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ER AT ANOTHER AREA HOSPITAL WHERE IT WAS DISCOVERED THAT THE PATIENT HAD DEVELOPED HYDRONEPHROSIS DUE TO A SLIGHT URETER INJURY. ON (B)(6) 2013, THE PATIENT UNDERWENT A TEMPORARY STENT PLACEMENT PROCEDURE. THE SURGEON INDICATED THAT THIS WAS DONE TO ALLOW THE DEFECT TO HEAL ON ITS OWN. ACCORDING TO THE SURGEON, HE LAST SPOKE TO THE PATIENT ON (B)(6) 2013 REGARDING HER CONDITION AND ADVISED HER THAT SHE SHOULD UNDERGO A URETER RE-IMPLANTATION PROCEDURE TO REPAIR HER URETER. THE SURGEON INDICATED THAT IT IS UNKNOWN IF THE PATIENT UNDERWENT THE RE-IMPLANTATION PROCEDURE. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE AND THE DAMAGE TO THE PATIENT'S URETER WAS NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM, BUT RATHER OCCURRED DUE TO THE PATIENT'S DIFFICULT ANATOMY. THE SURGEON INDICATED THAT A URETER INJURY IS A POTENTIAL COMPLICATION OF A HYSTERECTOMY SURGICAL PROCEDURE, AND CAN LIKELY OCCUR REGARDLESS OF THE SURGICAL MODALITY USED." }, { "mdr_text_key": "21918124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS DETERMINED THAT THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT WAS NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. PER THE INFORMATION PROVIDED BY THE SURGEON, THE INJURY SUSTAINED BY THE PATIENT OCCURRED DUE TO A HER DIFFICULT ANATOMY. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI HYSTERECTOMY PROCEDURE THE PATIENT SUSTAINED A URETER INJURY REQUIRING THE PATIENT TO UNDERGO ADDITIONAL PROCEDURES TO REPAIR THE DEFECT." } ], "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": "" } ] }