{ "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": "2955842-2013-04041", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20131004", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110127", "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": "20131007", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "502360", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131004", "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": "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20131004", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "51 YR", "patient_sex": "", "patient_weight": "57", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Burn, Thermal" ] } ], "distributor_city": "", "date_report": "20131004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3388861", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131004", "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": "20103319", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011, AND ALLEGED TO HAVE INJURIES INCLUDING A PUNCTURED BLADDER DUE TO A THERMAL BURN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME." }, { "mdr_text_key": "20168316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATION(S) EXPERIENCED BY THE PATIENT. THE INFORMATION RECEIVED 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. INTUITIVE SURGICAL INC. (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: A PATIENT'S ATTORNEY ALLEGED A PUNCTURED BLADDER INJURY DUE TO A THERMAL BURN AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "11397610", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED THE OPERATIVE REPORT AND MEDICAL RECORDS FROM THE ATTORNEY REPRESENTING THE PATIENT WHO UNDERWENT A DA VINCI SI RIGHT SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS TAKING AN ADDITIONAL 30 MINUTES, AND CYSTOSCOPY. BASED ON THE OPERATIVE REPORT, THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS RIGHT ADNEXAL COMPLEX MASS IN A POSTMENOPAUSAL FEMALE. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON INDICATED THAT SIGNIFICANT ADHESIONS OF THE BOWEL IN THE RIGHT LOWER QUADRANT WERE OBSERVED SUCH THAT ONE COULD NOT VISUALIZE THE ADNEXAL MASS. EXTENSIVE DISSECTION WAS CARRIED OUT TO RELEASE THE ADHESIONS BETWEEN THE ABDOMINAL WALL, PELVIS, AND THE BOWEL. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE SURGEON PERFORMED A CYSTOSCOPY USING NORMAL SALINE AS THE IRRIGATING MEDIUM. FREE SPILL OF INDIGO CARMINE INTO THE BLADDER WAS OBSERVED WITHOUT INCIDENT. THE PATIENT WAS DISCHARGED HOME ON POST-OP DAY 1 ((B)(6) 2011). ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT DEVELOPED SYMPTOMS OF SEVERE LOWER ABDOMINAL PAIN, URINARY RETENTION, AND SOME HEMATURIA ON (B)(6) 2011. THE FOLLOWING DAY, THE PATIENT WAS EVALUATED IN AN EMERGENCY DEPARTMENT FOR WORSENING SYMPTOMS OF ABDOMINAL PAIN. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS SHOWED MILD TO MODERATE ABDOMINAL PELVIC ASCITES OF UNKNOWN ORIGIN. IN ADDITION, AN ABDOMINAL X-RAY SHOWED A LARGE AMOUNT OF ENTERIC CONTRAST. HOWEVER, A CT CYSTOGRAM PERFORMED ON THE PATIENT DID NOT SHOW ANY EXTRAVASATION. ON (B)(6) 2011, THE PATIENT UNDERWENT A CYSTOSCOPY, BILATERAL RETROGRADE PYELOGRAMS, AND A CYSTOGRAM. THE PATIENT WAS FOUND TO HAVE AN INJURY TO THE POSTERIOR WALL OF THE BLADDER NEAR DOME. THE SURGEON NOTED THAT THE INJURY APPEARED TO BE THERMAL IN NATURE. THE REST OF THE BLADDER WAS FOUND TO BE NORMAL AND BOTH URETERAL ORIFICES EFFLUXED CLEAR URINE. THE BILATERAL RETROGRADE PYELOGRAMS REVEALED NO EVIDENCE OF EXTRAVASATION OR HYDRONEPHROSIS. AT THE CONCLUSION OF THE PROCEDURE, THE SURGEON INTRODUCED A 16 FRENCH FOLEY CATHETER AND PERFORMED A CYSTOGRAM. THE SURGEON DID NOT SEE ANY GROSS EXTRAVASATION. A 20 FRENCH FOLEY CATHETER WAS THEN PLACED AND THE PATIENT WAS SENT TO THE RECOVERY ROOM. THE SURGEON'S PLAN WAS TO KEEP THE CATHETER IN PLACE FOR 7 DAYS. THE SURGEON NOTED THAT IT WAS HIS BELIEF THE BLADDER WOULD HEAL. NO ADDITIONAL INFORMATION WAS PROVIDED POST-OPERATIVELY." } ], "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": "10/31/2013" } ] }