{ "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": "2955842-2013-03158", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20100226", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "409818", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "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": "", "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": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20130823", "sequence_number_treatment": [ "DA VINCI SURGICAL SYSTEM, INSTRUMENTS, ACCESSORIE" ], "sequence_number_outcome": [ "Hospitalization", " L", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Cyst(s)", "Extravasation", "Fever", "Inflammation", "Pain", "Abnormal Vaginal Discharge", "Injury", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305632", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130725", "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": "21406649", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE LIMITED INFORMATION AND LACK OF ANY ADDITIONAL CLINICAL INFORMATION FROM THE HOSPITAL OR SURGEON, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE DOCUMENTATION PROVIDED DOES NOT HAVE ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE, HOWEVER AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A URETERAL INJURY DURING A DA VINCI HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "21266087", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE INFORMATION RECEIVED STATES THAT THE PATIENT SUSTAINED A THERMAL MONOPOLAR INJURY TO HER URETER DURING THE SURGICAL PROCEDURE WHICH CAUSED DOCUMENTED EXTRAVASATION OF URINE INTO THE PERITONEAL CAVITY AND THAT THIS WAS DIRECTLY CAUSATIVE TO THE FLUID COLLECTION AND INCREASED PELVIC PAIN THAT WAS THEN MISDIAGNOSED AS AN OVARIAN CYST. THE INFORMATION STATES THAT THE PATIENT UNDERWENT SURGICAL CASTRATION AS A DIRECT RESULT OF A COMPLICATION FROM HER DA VINCI HYSTERECTOMY. THE DOCUMENTATION STATES THAT AT THE TIME OF THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL UTERUS, NORMAL OVARIES BILATERALLY, AND NO EVIDENCE OF EXTRA-CERVICAL DISEASE. DURING POST OPERATIVE FOLLOW UP THE PATIENT EXPERIENCED SHOULDER PAIN AND RECEIVED PHYSICAL THERAPY FOR A DIAGNOSIS OF COMPRESSION FROM SURGICAL POSITIONING. THE PATIENT RECEIVED NON STEROID ANTI-INFLAMMATORY TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, THE DOCUMENTATION STATES THAT THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF SEVERE ABDOMINAL PAIN AND SIGNIFICANT VAGINAL DRAINAGE. THE PATIENT WAS EVALUATED BY UROLOGY SERVICE AND UNDERWENT CYSTOSCOPY, CYSTOGRAM UNDER ANESTHESIA, BILATERAL RETROGRADE PYELOGRAM, AND RIGHT URETERAL STENT PLACEMENT. THE SURGERY WAS STATED TO SHOW RIGHT URETERAL EXTRAVASATION. IN (B)(6) 2011 THE PATIENT WAS EVALUATED FOR PELVIC PAIN AND FOUND TO HAVE A LARGE LEFT SIDED PELVIC CYSTIC MASS, WHICH WAS FELT TO BE CONSISTENT WITH AN OVARIAN CYST. AFTER RECEIVING ANTIBIOTICS, THE PATIENT UNDERWENT A DA VINCI BILATERAL SALPINGOOPHORECTOMY PROCEDURE AND THE OPENING A FLUID COLLECTION IN THE PELVIS. IT WAS INDICATED THAT THE PATIENT HAD INCREASING FEVER AND LEUKOCYTOSIS AND DEVELOPED AN ILEUS AND PARTIAL SMALL OBSTRUCTION, WHICH REQUIRED AN EXTENDED HOSPITALIZATION. THE PATIENT WAS DISCHARGED WITH ON ORAL ANTIBIOTICS FROM THE HOSPITAL ON (B)(6) 2011. THE INFORMATION PROVIDED STATES THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A CT SCAN. THE CT SCAN SHOWED A MARKED INFLAMMATION AND THICKENING OF THE SIGMOID COLON AND AN INFLAMMATORY PROCESS INVOLVING THE BOWEL. A RADIOLOGIST REVIEWED THE FILMS FROM 2010 AND NOTED THAT THE PATIENT HAD MULTIPLE FLUID COLLECTIONS IN THE PELVIS WHICH MAY HAVE BEEN RELATED TO URINARY INJURY. INFECTION OF THESE COLLECTIONS WAS SUSPECTED AND INFLAMMATION OF THE SMALL BOWEL AND COLON MAY BE SECONDARY. THE PATIENT ADMITTED AND TREATED WITH ANTIBIOTICS FOR 7 ADDITIONAL DAYS. SHE HAD A PIC LINE PLACED AND RECEIVED HOME INFUSIONS IN (B)(6) 2011." } ], "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": "" } ] }