{ "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": "2955842-2015-00431", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20150313", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20110627", "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": "20150313", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "175682", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150313", "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", "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": [ "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250824", "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": "20150313", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "42 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Necrosis", "Pain", "Abnormal Vaginal Discharge", "Injury", "Blood Loss", "Heavier Menses", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20150116", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4600547", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150116", "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": "13003620", "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2011. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. IN ADDITION, AN UNIDENTIFIED GREEN FRAGMENT WAS FOUND TO HAVE BEEN RETAINED INSIDE THE PATIENT. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATIONS AND THE SOURCE OF THE RETAINED FRAGMENT ARE UNKNOWN." }, { "mdr_text_key": "5466316", "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-ASSISTED HYSTERECTOMY ON (B)(6) 2011 FOR PELVIC PAIN, MENORRHAGIA, AND FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. PER THE OPERATIVE REPORT, THE UTERUS AND CERVIX REQUIRED MORCELLATION TO REMOVE DUE TO SIZE. THE VAGINAL CUFF WAS ALSO LEFT TO CLOSE ON ITS OWN, AS IT WAS NOTED TO BE VERY DEEP AND HIGH AND PROVED TO BE TECHNICALLY VERY DIFFICULT TO CLOSE. THE VAGINA WAS SUBSEQUENTLY PACKED WITH 1 INCH IODOFORM TAPE. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. A DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. THE PATIENT PRESENTED TO HER DOCTOR THE DAY AFTER DISCHARGE FOR A MASS IN HER VAGINA. HER VAGINAL PACKING WAS REMOVED AND SHE WENT HOME. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF SEVERE FLANK PAIN AND WAS ADMITTED WITH PRESUMED PYELONEPHRITIS. SHE WAS TREATED WITH ANTIBIOTICS, AND A CT IVP SHOWED NO INJURY TO THE RIGHT URETER AND INCOMPLETE VISUALIZATION OF THE LEFT URETER. PERSISTENT COPIOUS WATERY VAGINAL DISCHARGE WAS NOTED. THE PATIENT WAS DISCHARGED (B)(6) 2011. THE NEXT DAY ((B)(6) 2011), THE PATIENT PRESENTED WITH COMPLAINTS OF CONTINUED PAIN AND VAGINAL DISCHARGE. A CT-SCAN SHOWED A 3.4 X 2.2 CM RIM-ENHANCING FLUID COLLECTION IN THE LEFT MID PELVIS WITH SOME ASSOCIATED INFLAMMATORY STRANDING AND FLUID WITHIN A DISTENDED VAGINA. FOLLOWING IV ADMINISTRATION OF INDIGO CARMINE, POSITIVE STAINING OF AN INSERTED TAMPON WAS NOTED. PER A PHYSICIAN'S NOTE, THE DOCTOR INDICATED, COULD NOT DETERMINE THE SIDE AND NOT CLEAR AT THIS POINT WHETHER IT IS SECONDARY TO A DELAYED THERMAL DAMAGE OR A PERFORATION AT THE TIME OF SURGERY. THE PATIENT WAS SUSPECTED TO HAVE A PROBABLE URETERAL INJURY AND VAGINAL CUFF ABSCESS VERSUS INFECTED URINOMA. ANTIBIOTICS AND PAIN MEDICATIONS WERE INITIATED. THAT SAME DAY, THE PATIENT UNDERWENT A CYSTOSCOPY, A BILATERAL RETROGRADE URETERAL PYELOGRAM, A RIGHT DISTAL URETERAL BALLOON DILATION, AND A RIGHT RIGID URETEROSCOPY. OPERATIVE FINDINGS INCLUDED A NARROW CALIBER RIGHT-SIDED URETERAL ORIFICE AND DISTAL URETER, EXTRAVASATION OF CONTRAST ON RETROGRADE PYELOGRAM APPROXIMATELY 2 CM ABOVE THE URETERAL ORIFICE, AND A LARGE OPEN CAVITY WITHIN THE RETROPERITONEUM CONTAINING NECROTIC TISSUE AND RETROPERITONEAL FAT. FURTHERMORE, IT WAS NOTED WE DID NOTE A SMALL GREEN OBJECT THAT MAY BE A RETAINED FOREIGN BODY, BUT WE WERE UNABLE TO EXACTLY IDENTIFY WITH [SIC] THIS OBJECT WAS. ON (B)(6) 2011, A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED, AND AN ANTEGRADE NEPHROSTOGRAM SHOWED DISTAL URETERAL TRANSECTION AND FREE FLOW OF CONTRAST INTO THE PELVIC CAVITY. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. THE DISCHARGE SUMMARY NOT PROVIDED." } ], "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": "" } ] }