{ "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": "2955842-2015-00364", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20150227", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110921", "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": [ "Consumer", "CONSUMER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150228", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "137962", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150227", "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", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*;*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20150227", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Incontinence", "Incontinence", "Pain", "Pain" ] } ], "distributor_city": "", "date_report": "20150203", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4555295", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150422", "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": "22151352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON 02/03/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT MW5038369 WITH THE FOLLOWING EVENT DESCRIPTION: ON (B)(6) 2011, I HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY USING THE DA VINCI INTERFACE. I SUFFERED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER. POST OP I DEVELOPED A FISTULA WITH URETERAL STRICTURE. I HAD A SURGICAL REPAIR ON (B)(6) 2011, WHICH DID NOT CHANGE THE TOTAL URINARY INCONTINENCE I SUFFERED AS A RESULT OF THE INITIAL SURGERY WITH THE DA VINCI. THE SECOND SURGERY DID NOT HELP AND (B)(6) 2014, I HAD ANOTHER REPAIR. I AM STILL SUFFERING FROM SEVERE INCONTINENCE. ON 02/25/2015, ISI CONTACTED THE PATIENT DIRECTLY AND OBTAINED THE FOLLOWING INFORMATION: THERE WERE NO REPORTS MADE TO HER FROM THE SITE THAT A MALFUNCTION OF THE DV SURGICAL SYSTEM OCCURRED DURING THE PROCEDURE. TO HER KNOWLEDGE, THE PATIENT EXPLAINED THAT DURING THE DV SURGICAL PROCEDURE, HER URETER WAS COMPLETELY CUT AND ANOTHER SURGEON WAS CALLED IN TO TRY AND REPAIR THE URETER. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2011 WITH A FEVER. ON (B)(6) 2011, THE PATIENT WAS SEEN BY ANOTHER PHYSICIAN DUE TO THE FEVER. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE DOCTOR'S VISIT. ON (B)(6) 2011,THE PATIENT UNDERWENT AN ULTRASOUND AND ON (B)(6) 2011, A STENT WAS PLACED IN HER KIDNEY. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT STATED THAT A TUBE WAS PLACED IN HER KIDNEY. ON (B)(6) 2011, THE PATIENT UNDERWENT OPEN SURGERY AS AN ATTEMPT TO REPAIR THE COMPLICATIONS THAT SHE HAD EXPERIENCED FROM THE INITIAL DA VINCI SURGICAL PROCEDURE. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. AS A RESULT OF HER COMPLICATIONS, THE PATIENT STATED THAT SHE WAS OUT OF WORK FOR 10 MONTHS. THE PATIENT INDICATED THAT SHE STILL HAS PELVIC PAIN AND INCONTINENCE." }, { "mdr_text_key": "19521002", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A VOLUNTARY REPORT (PATIENT IDENTIFIER RB) FROM THE SITE WITH THE FOLLOWING EVENT DESCRIPTION: PT. STATES THAT SHE HAD A TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY WITH DA VINCI DEVICE IN 2011. SHE STATED THAT DURING THIS PROCEDURE THERE WAS A COMPLETE TRANSECTION OF HER RIGHT DISTAL URETER. SHE STATES THAT SHE HAD SEVERAL PROCEDURES FOLLOWING IN 2011, HOWEVER SHE REMAINS INCONTINENT. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE EXPERIENCED OPERATIVE COMPLICATIONS AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE. IN ADDITION, THE PATIENT CLAIMED THAT SHE HAD TO UNDERGO FURTHER UNSPECIFIED PROCEDURES POST-OPERATIVELY." }, { "mdr_text_key": "22357715", "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 OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. 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. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2011 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 INTRA-OPERATIVE INJURY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE EXPERIENCED OPERATIVE COMPLICATION AS A RESULT OF UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "34343754", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2011 FOR TOTAL UTERINE PROCIDENTIA AND CYSTOCELE. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE DA VINCI OPERATIVE REPORT, THE SURGEON NOTED, WHEN GOOD HEMOSTASIS WAS NOTED, THE CERVIX WAS AMPUTATED FROM THE VAGINA AROUND THE COLPOTOMY CUFF WITH THE MONOPOLAR CURVED SCISSORS WITHOUT COMPLICATIONS. THIS WAS THEN BROUGHT OUT THROUGH THE VAGINA AND LEFT IN THE VAGINA TO MAINTAIN THE PNEUMOPERITONEUM. THE VAGINAL CUFF WAS THEN CLOSED WITH A V-LOC SUTURE IN A RUNNING UNLOCKED FASHION WITHOUT COMPLICATIONS. WHILE DISSECTING THE BLADDER FURTHER OFF THE VAGINA TO PREPARE FOR PLACEMENT OF THE ANTERIOR MESH, THE SURGEON DISCOVERED THAT THE RIGHT URETER HAD BEEN TRANSECTED WHICH WAS NOTED AS A COMPLICATION OF THE SURGICAL PROCEDURE. TWO UROLOGISTS WERE CONSULTED INTRAOPERATIVELY. ONE OF THE UROLOGISTS RE-APPROXIMATED AND RE-SUTURED THE RIGHT URETER USING THE DA VINCI SURGICAL SYSTEM. THE OTHER UROLOGIST PLACED A URETERAL STENT. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 25 CC. PER A PHYSICIAN NOTE, THE PATIENT'S RIGHT DISTAL URETER WAS NOTED TO BE TRANSECTED AFTER THE UTERUS WAS REMOVED. ON (B)(6) 2011, THE PATIENT UNDERWENT A CYSTOSCOPY WITH REMOVAL OF THE URETERAL STENT. AN ULTRASOUND PERFORMED ON (B)(6) 2011 NOTED THAT THE MID RIGHT URETER WAS MILDLY DILATED. THE BLADDER APPEARED NORMAL. ON (B)(6) 2011, THE PATIENT UNDERWENT A CYSTOSCOPY WITH ATTEMPTED RIGHT DOUBLE-J STENT PLACEMENT FOR URINARY INCONTINENCE. THE PATIENT HAD A POST-OP DIAGNOSIS OF RIGHT URETEROVAGINAL FISTULA WITH URETERAL STRICTURE. A SMALL LEAK IN THE DISTAL RIGHT URETER WAS NOTED TO BE FISTULIZING TO THE VAGINAL VAULT. A SMALL FISTULA FROM THE RIGHT DISTAL URETER WAS ABOUT 2 CM FROM THE BLADDER. A RIGHT NEPHROSTOMY TUBE PLACEMENT WAS PLANNED. ON (B)(6) 2011 THE PATIENT UNDERWENT RIGHT PERCUTANEOUS NEPHROSTOMY TUBE INSERTION. AN ANTEGRADE NEPHROSTOGRAM DEMONSTRATED THAT THE MAJORITY OF CONTRAST EXTENDED THROUGH THE URETEROVAGINAL FISTULA. ON (B)(6) 2011, A NEPHROSTOGRAM WAS PLANNED WITH HOPE OF PLACING A URETERAL STENT. REPEATED ATTEMPTS WERE PERFORMED BUT THE PHYSICIAN WAS UNABLE TO NAVIGATE THROUGH THE DISTAL URETEROVESICAL JUNCTION. A NEPHROSTOMY TUBE WAS REPLACED THROUGH THE EXISTING TRACT. THE PATIENT WAS ADMITTED FROM (B)(6) 2011 WITH A DIAGNOSIS OF A URETEROVAGINAL FISTULA. ON (B)(6) 2011, THE PATIENT UNDERWENT EXPLORATION AND RIGHT URETERAL REIMPLANTATION FOR A PRE- AND POST- OPERATIVE DIAGNOSIS OF A URETEROVAGINAL FISTULA. ON (B)(6) 2011, THE NEPHROSTOMY TUBE WAS REMOVED WITH A WELL POSITIONED RIGHT DOUBLE-J STENT NOTED. ON (B)(6) 2011, THE MID TO DISTAL INCISION WAS NOTED TO BE A LITTLE ERYTHEMATOUS AND WARM. THE PATIENT'S ANTIBIOTIC WAS CHANGED TO KEFLEX. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THAT SAME DAY. ON (B)(6) 2012, THE PATIENT'S CATHETER WAS REMOVED. ON (B)(6) 2012, THE PATIENT PRESENTED FOR STENT REMOVAL AND WAS DOING WELL. A BILATERAL KIDNEY ULTRASOUND WAS PERFORMED ON (B)(6) 2012 AND IT WAS NOTED THAT THE PREVIOUSLY DESCRIBED DILATED RIGHT URETER WAS NO LONGER EVIDENT. THE PATIENT WAS NOTED TO HAVE NORMAL APPEARING KIDNEYS BILATERALLY WITH NO HYDRONEPHROSIS OR HYDROURETER. THE BLADDER WAS NOTED AS UNREMARKABLE. THE LAST MEDICAL RECORD WAS DATED (B)(6) 2012. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A COMPLETE TRANSECTION OF THE RIGHT DISTAL URETER WHILE UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS STILL UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE OR CAUSED/CONTRIBUTED TO THE PATIENT'S INTRA-OPERATIVE INJURY." } ], "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": "04/23/2015;09/25/2015" } ] }