{ "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": "2955842-2013-05196", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131114", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20121212", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "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": "20131115", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "590232", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131114", "brand_name": "DA VINCI 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": "", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20131114", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula" ] } ], "distributor_city": "", "date_report": "20131105", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3470030", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131115", "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": "18367611", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED VOLUNTARY REPORT MW5030296 WITH THE FOLLOWING DESCRIPTION: MD PERFORMED A ROUTINE HYSTERECTOMY USING A DA VINCI ROBOT AT XX IN XX. HE DAMAGED (CUT) MY LEFT URETER CAUSING A FISTULA. DR XX DIDN'T REALIZE IT AT THE TIME OF SURGERY AND I WAS RELEASED. THIS FISTULA CAUSED MY KIDNEY TO MALFUNCTION REQUIRING EMERGENCY HOSPITALIZATION. IT WAS STILL UNDIAGNOSED WHILE IN THE HOSPITAL. ON XX 2013 DR XX ORDERED A CT SCAN TO DETERMINE THE CAUSE OF THE FISTULA. I HAD OUTPATIENT SURGERY ON XX 2013 AND A NEPHROSTOM TUBE WAS INSERTED INTO MY KIDNEY. ON XX 2013 DR XX PERFORMED ANOTHER OUTPATIENT SURGERY AND PUT A DOUBLE J STENT INTO MY DAMAGED URETER WHICH WAS IN FOR 6 WEEKS." }, { "mdr_text_key": "11297819", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER CONFIRMED THAT THE PATIENT HAD A DV HYSTERECTOMY PROCEDURE PERFORMED AT THE SITE ON (B)(6) 2012. BASED ON HER REVIEW OF THE OPERATIVE REPORT, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL WITH REPORTED COMPLAINTS OF PELVIC PAIN. A CT SCAN PERFORMED DURING THE HOSPITALIZATION REVEALED A LEFT PELVIC ABSCESS AND LEFT HYDRONEPHROSIS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, THE PATIENT UNDERWENT A PROCEDURE FOR PLACEMENT OF A NEPHROSTOMY TUBE. ON (B)(6) 2013, THE PATIENT UNDERWENT A PROCEDURE FOR REPOSITIONING OF THE NEPHROSTOMY AND PLACEMENT OF A URETHRAL STENT. THE RISK MANAGER DID NOT FIND ANY DOCUMENTATION IN THE PATIENT'S MEDICAL RECORDS AS TO WHAT THE POSSIBLE CAUSE WAS FOR THE PATIENT'S REPORTED POST-OP COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE RISK MANAGER." }, { "mdr_text_key": "18399029", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ON 11/13/2013, ISI CONTACTED THE PATIENT AND WAS ABLE TO OBTAIN THE NAME OF THE FACILITY WHERE THE SURGICAL PROCEDURE WAS PERFORMED AND THE NAME OF THE SURGEON WHO PERFORMED THE PROCEDURE. ACCORDING TO THE PATIENT, HER URETER WAS FRIED. 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." } ], "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": "12/02/2013" } ] }