{ "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": "2955842-2013-04796", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131031", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20070207", "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": "20131031", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "558977", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131031", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20131031", "sequence_number_treatment": [ "DA VINCI S SURG SYS INSTRMNTS, ACCESSORIES & ESU" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "44 YR", "patient_sex": "", "patient_weight": "72", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fever", "Fistula", "Incontinence", "Pain", "Scar Tissue", "Tissue Damage", "Urinary Frequency / Polyuria", "Dysuria" ] } ], "distributor_city": "", "date_report": "20131002", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3440442", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131002", "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": "3795491", "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 WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY, BSO WITH LYSIS OF ADHESIONS AND REPAIR OF A SMALL UMBILICAL HERNIA ON (B)(6) 2007. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE SUBSEQUENT IMAGING AND STENT PLACEMENT REPORTS, AND THE OP FOR THE PATIENT'S URETERAL REIMPLANTATION. NO MEDICAL HISTORY REGARDING THE PATIENT WAS PROVIDED TO ISI. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER EXTENSIVE LYSIS OF OMENTAL ADHESIONS TO AN UMBILICAL HERNIA, THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND DIVISION OF THE INFUNDIBULOPELVIC, ROUND, AND BROAD LIGAMENTS. THE UTERINE ARTERIES AND THE CARDINAL LIGAMENTS WERE CAUTERIZED AND DIVIDED. THE COLPOTOMY WAS PERFORMED AGAINST A V-CARE COLPOTOMY CUP, THE UTERINE STRUCTURES REMOVED THROUGH THE VAGINA. THE VAGINAL CUFF WAS SUTURED CLOSED, THE EXISTING FACIAL DEFECT IN THE ANTERIOR ABDOMINAL WALL CLOSED, AND THE SURGERY COMPLETED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE FOLEY WAS DRAINING BLUE URINE FROM IV INDIGO CARMINIE INDICATING GOOD URINARY FUNCTION, AND THERE WAS NO EXTRAVASATION OF BLUE DYE INTO THE ABDOMEN. REPORTEDLY, ON (B)(6) 2007 THE PATIENT PRESENTED WITH A 3 MONTH HISTORY OF UNCONTROLLABLE URINATION AND INCONTINENCE. A CT WITH CONTRAST SHOWED SEVERE RIGHT HYDRONEPHROSIS AND HYDROURETER, A RIGHT DEEP PELVIC MASS, DISTAL RIGHT URETERAL VAGINAL FISTULA. ON (B)(6) 2007, PATIENT UNDERWENT CYSTOSCOPY, RIGHT RETROGRADE PYELOGRAM, RIGHT URETEROSCOPY AND SUCCESSFUL RIGHT DOUBLE-J STENT INSERTION FOR RIGHT HYDRONEPHROSIS, RIGHT URETEROVAGINAL FISTULA, RIGHT URETEROPELVIC JUNCTION OBSTRUCTION. ON (B)(6) 2007 A FOLLOW-UP CT ANGIO OF THE PATIENT'S ABDOMEN SHOWED THE STENT WAS IN PLACE WITH MODERATE RIGHT HYDRONEPHROSIS AND A THICKENED RIGHT URETER IN THE PROXIMAL PORTION. ON (B)(6) 2007 THE PATIENT HAD THE STENT REMOVED WITHOUT COMPLICATIONS ON (B)(6) 2007 A CT ANGIO SHOWED RIGHT HYDRONEPHROSIS WITH HYDROURETER TO THE LEVEL OF THE DISTAL ONE THIRD OF THE RIGHT URETER CONSISTENT WITH SHORT SEGMENT STRICTURE AT THAT POINT. ON (B)(6) 2007 THE PATIENT UNDERWENT CYSTOSCOPY, RIGHT RETROGRADE URETEROSCOPY, STRICTURE DILATION AND DOUBLE-J STENT PLACEMENT. ON (B)(6) 2007, THE PATIENT WAS RECOMMENDED TO HAVE URETERAL REIMPLANTATION BECAUSE OF PERSISTENT STRICTURE. ON (B)(6) 2008 THE PATIENT UNDERWENT A CT. THE CT IMAGING SHOWED THAT THE STENT WAS IN PLACE WITH DILATED PROXIMAL AND MID RIGHT URETER WITH PROMPT EXCRETION OF CONTRAST FROM BOTH KIDNEYS REPORTEDLY ON (B)(6) 2008 THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PYRUIA AND FEVER AND RIGHT FLANK PAIN. CT IMAGING TO WORK UP RIGHT FLANK PAIN AND RULE OUT KIDNEY STONES, SHOWED THE RIGHT URETERAL STENT IN PLACE AND STRANDING AROUND THE RIGHT KIDNEY, NO STONE, AND PERSISTENT HYDRONEPHROSIS ON THE RIGHT. ON (B)(6) 2008, THE PATIENT UNDERWENT CYSTOSCOPY, DOUBLE-J STENT EXCHANGE, RIGHT URETEROSCOPY AND RIGHT URETERAL STRICTURE DILATION. THE PATIENT WAS STARTED ON DIFLUCAN SECONDARY TO YEAST IN URINE, AND WAS DISCHARGED HOME ON (B)(6) 2008. ON (B)(6) 2008, THE PATIENT UNDERWENT A CT. THE CT IMAGING SHOWED A SLIGHT DILATATION OF THE RIGHT RENAL PELVIS AND RIGHT RENAL COLLECTING SYSTEM WITH A STENT DISPLACED TO THE URETEROPELVIC JUNCTION. SIGNIFICANT IMPROVEMENT OF HYDRONEPHROSIS NOTED IN COMPARISON TO (B)(6) 2008 FILMS. ACCORDING TO THE INFORMATION IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2008, THE PATIENT UNDERWENT A LAPAROSCOPIC URETEROLYSIS, URETERONEOCYSTOSTOMY WITH REANASTOMOSIS FOR PERSISTENT RIGHT URETHRAL STRICTURE. INTRAOPERATIVELY, DENSE SCAR TISSUE WAS EXCISED FROM THE BLADDER OVERLYING THE URETER, AND THE URETER WAS MOBILIZED, PROXIMALLY SPATULATED AND ANASTOMOSED ONTO THE BLADDER IN A TENSION FREE MANNER. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2008, THE PATIENT UNDERWENT A CYSTOGRAM. THE CYSTOGRAM SHOWED NO INDICATION OF LEAKAGE AND PATIENT WAS REPORTED TO BE DOING WELL POST THE URETERAL REIMPLANTATION PROCEDURE. ON (B)(6) 2008 THE STENT WAS REMOVED WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION REGARDING THE PATIENT WAS PROVIDED TO ISI AFTER THIS DATE." }, { "mdr_text_key": "11449545", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE 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. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS FOLLOWING A DA VINCI S 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": "" } ] }