{ "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": "2955842-2016-00030", "type_of_report": [ "Followup" ], "product_problem_flag": "N", "date_received": "20160113", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140505", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160113", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "23186", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160113", "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 A6.0P9", "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", "Insufficient Device Problem Information" ], "reporter_state_code": "SC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250725", "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": "20160113", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Burn(s)", "Incontinence", "Nausea", "Scarring", "Sepsis", "Swelling", "Complaint, Ill-Defined", "Injury", "Bacterial Infection", "Burn(s)", "Incontinence", "Nausea", "Scarring", "Sepsis", "Swelling", "Complaint, Ill-Defined", "Injury" ] } ], "distributor_city": "", "date_report": "20151214", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5363817", "removal_correction_number": "", "number_devices_in_event": "", "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": "38866525", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 01/13/2016, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2014: THE PATIENT HAD A LARGE, (B)(6) UTERUS AND MULTIPLE BIG FIBROIDS. PRE-OPERATIVELY, THE SURGEON'S PLAN WAS TO REMOVE THE PATIENT'S UTERUS AND CERVIX. HOWEVER, DUE TO THE SIZE OF THE PATIENT'S UTERUS AND LOCATION OF MULTIPLE FIBROIDS, THE SURGEON MADE THE INTRA-OPERATIVE DECISION TO LEAVE THE CERVIX INSIDE THE PATIENT. THE SURGEON INDICATED THAT SHE DID NOT WANT TO TAKE ANY RISKS WITH POSSIBLY CAUSING ANY INTRA-OPERATIVE DAMAGE. ACCORDING TO THE SURGEON, THE REASON TO LEAVE THE CERVIX INSIDE THE PATIENT WAS STRICTLY FOR ANATOMICAL REASONS. THE SURGEON EXPLAINED THAT SHE COULD NOT SEE AROUND THE FIBROIDS. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS, OR ACCESSORIES. THE DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. THE SURGEON STATED THAT A FEW WEEKS POST-OPERATIVELY, THE PATIENT CAME BACK TO THE HOSPITAL COMPLAINING OF URINE LEAKING FROM HER VAGINA. A FISTULA WAS FOUND TO HAVE FORMED BETWEEN THE PATIENT'S URETER AND CERVIX. THE SURGEON BELIEVES THAT THE FISTULA MAY HAVE BEEN POSSIBLY CAUSED BY SOME SORT OF THERMAL SPREAD. SHE COULD NOT THINK OF ANY OTHER REASON AS TO WHY THE FISTULA FORMED. THE SURGEON INDICATED THAT THE URETER WAS NOT TRANSECTED DURING THE DA VINCI SURGICAL PROCEDURE. A UROLOGIST PLACED A STENT THAT WAS EVENTUALLY REPLACED AT A LATER TIME AFTER FURTHER LEAKING WAS FOUND. ACCORDING TO THE SURGEON, THE PATIENT CAME IN FOR A 1 YEAR POST-OPERATIVE FOLLOW-UP VISIT AND NO ISSUES WERE REPORTED TO HER. THE SURGEON WAS NOT AWARE THAT THE PATIENT ALLEGEDLY DEVELOPED A SEPSIS INFECTION, WHICH WAS REPORTED IN THE INITIAL MDR FOR THIS COMPLAINT. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND SUSTAINED A RIGHT URETER INJURY THAT REQUIRED REPAIR. HOWEVER, THE CAUSE OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATION IS STILL UNKNOWN." }, { "mdr_text_key": "35820476", "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 COMPLICATION EXPERIENCED BY THE PATIENT. ISI HAS ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. 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) 2014 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE AND SUSTAINED A RIGHT URETER INJURY THAT REQUIRED REPAIR. THE PATIENT ALSO INDICATED THAT SHE DEVELOPED POST-OPERATIVE SEPSIS. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "35820477", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AS A RESULT OF UNDERGOING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE PATIENT CLAIMED THAT HER RIGHT URETER WAS BURNED, NICKED, OR CUT. IN RELATION TO THE REPORTED EVENT, ON 01/07/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5058544 WITH THE FOLLOWING EVENT DESCRIPTION: MY GYNECOLOGIST RECOMMENDED THE DA VINCI TO ME. SHE SAID IT WAS THE WAY TO GO. ON (B)(6) 2014, I HAD MY PLANNED SURGERY BUT NEVER RECOVERED. I WAS NAUSEATED THE FIRST WEEK (B)(6) BACK TO WORK, SO I HAD CALLED AND ASKED FOR SOMETHING TO CONTROL THE NAUSEA. I HAD NO BLADDER CONTROL BEGINNING (B)(6) . I HAD A WETTING ACCIDENT AT WORK. I THOUGHT I HAD A BAD UTI. I KEPT CALLING MY DR'S OFFICE AND FINALLY GOT IN TO SEE HER AND SHE REFERRED ME THE SAME DAY TO A UROLOGIST. I HAD TO WEAR ADULT DIAPERS SINCE (B)(6). ON (B)(6) 2014 MET WITH A UROLOGIST ON A FRIDAY, AND HE TOLD ME THAT HE NEEDED TO SEE ME IN THE OPERATING ROOM ON THE FOLLOWING MONDAY TO PLACE A STENT IN. THE RIGHT URETER HAD STOPPED WORKING. ON (B)(6) 2014 THE STENT WAS REMOVED. SIX DAYS LATER, (B)(6), I FELL ILL AT WORK. MY STOMACH HAD SWELLED AND I COULD HEAR WATER GUSHING THROUGH MY STOMACH. I CALLED MY DOCTOR. HE SAID GO GET MRI AT THE HOSPITAL AND BRING HIM THE DVD. I WAS IN HIS OFFICE AT 1:30 AND HE SAID I NEED TO SEE YOU IN THE OPERATING ROOM AT 2:00. I HAD FLUID BACKING UP IN THE RIGHT KIDNEY. ON (B)(6), DR (B)(6) REPLACED THE SENT. ON (B)(6) 2014, I WENT TO (B)(6) FOR A SECOND OPINION. THE DOCTOR THERE SAID YOUR DOCTOR IN (B)(6) IS DOING EVERYTHING THAT I WOULD HAVE DONE AND HE IS REQUESTING ALL OF THE TESTS THAT I WOULD HAVE REQUESTED. ON (B)(6) 2014, I HAD A PYELOGRAM TEST SCHEDULED IN THE OPERATING ROOM. AFTERWARDS, MY DOCTOR TOLD ME THAT HE COULDN'T GET THE DYE PAST WHERE HE NEEDED IT TO. ON (B)(6) 2014, I MET WITH MY DOCTOR. HE TOLD ME THAT I HAVE DONE ALL THAT I COULD DO TO GET USE THE DA VINCI BECAUSE THAT'S HOW YOU ENDED UP HERE, NOT SAYING THAT THE DA VINCI IS NOT A GOOD MACHINE. ON (B)(6) 2014, I HAD MY SURGERY. NOTHING COULD HAVE PREPARED ME FOR IT. I WAS SO SICK. I WAS TOLD THAT THEY HAD TO MOVE SOME OF THE ORGANS ON MY RIGHT TO REPAIR ME. I LOST MY SKIN COLOR, AND I TRULY THOUGHT I WAS GOING TO DIE. I ENDED UP BACK IN THE HOSPITAL FOR A WEEK AFTER, FOR SEVERAL DAYS, WITH A SEPSIS INFECTION. I COULDN'T DO ANYTHING FOR MYSELF. I WAS OUT OF WORK ALL MONTH. I HAVE A LONG UGLY SCAR FROM THE BIKINI LINE UP AROUND PAST MY NAVEL. MY URETER IS SHORTER ON THE RIGHT SIDE. I SUFFER FROM BACK PAIN AND PAIN IN MY RIGHT SIDE BECAUSE OF THE SHORTER URETER. I HAVE MORE INTENSE PAIN ON THAT SIDE. AS A RESULT OF USING THE DA VINCI ROBOT, I WILL REQUIRE LIFELONG MEDICAL CARE. NO I HAVE TO WORRY ABOUT SCAR TISSUE ON MY URETER. I DON'T DRINK ON LONG TRIPS BECAUSE THE URGE TO GO IS SO STRONG THAT I WILL HAVE AN ACCIDENT. I AM ONLY (B)(6). MY INSURANCE HAS PAID OUT OVER $(B)(6) AND STILL HAVE APPOINTMENTS FOR THE NEXT TWO WEEKS FOR AN ULTRASOUND AND TO MEET WITH THE UROLOGIST WHO PERFORMED THE REPAIR. I HAVE MISSED 196.40 HOURS FROM WORK. I DEVELOPED A SEPSIS INFECTION. I AM SO HURT BECAUSE I HAVE BEEN LEFT OUT HERE ALONE. NO ONE CARES. I ALMOST DIED." } ], "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": "02/06/2016" } ] }