{ "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": "2955842-2013-03199", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K070684", "date_of_event": "20080611", "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", "Consumer" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "417057", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "brand_name": "DA VINCI STANDARD 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": "IS1200 A4.3P9", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "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": "20130826", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "35 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hematoma", "Hemorrhage/Blood Loss/Bleeding", "Pain", "Seroma", "Abnormal Vaginal Discharge" ] } ], "distributor_city": "", "date_report": "20131107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306717", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131107", "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": "18855085", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25TH, 2013 INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO HAD A DA VINCI ASSISTED LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2008. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATIONS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE PATIENT HAD A CT SCAN OF HER ABDOMEN/PELVIS ON (B)(6) 2008 WHICH REVEALED FLUID COLLECTION IN THE PELVIS AND RECTUM, MOST LIKELY CONSISTENT WITH SEROMA OR HEMATOMA. THE PATIENT WAS SEEN FOR SIMILAR SYMPTOMS AND RECEIVED COURSE OF AUGMENTIN ON (B)(6) 2008. THE PATIENT EXPERIENCED A REACTION TO AUGMENTIN (JOINT PAINS) AND DISCONTINUED ANTIBIOTICS ON (B)(6) 2008. ON (B)(6) 2008 THE PATIENT EXPERIENCED ORANGE/BLOOD-TINGED WATERY VAGINAL BLEEDING AND FELT ACHY. SHE SOAKED THROUGH SEVERAL PADS OVER THE COURSE OF 2-3 HOURS, BUT BLEEDING THEN SUBSIDED. ON THE MORNING OF (B)(6) 2008, THE PATIENT CONTINUED TO HAVE WATERY VAGINAL BLEEDING AND NEW ONSET FEVER TO 104.8 WITH CHILLS. THE PATIENT TOOK MOTRIN AND THEN CAME TO THE HOSPITAL PER HER PHYSICIAN'S RECOMMENDATION. THE PATIENT WAS ADMITTED AND WAS STARTED ON ANTIBIOTICS. SHE WAS EXPERIENCING SPONTANEOUS DRAINAGE FROM THE VAGINA AND THUS NO ATTEMPT AT ADDITIONAL DRAINAGE WAS UNDERTAKEN. THE PATIENT WAS DISCHARGED ON (B)(6) 2008. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS." }, { "mdr_text_key": "19293316", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THE DOCUMENTATION PROVIDED DOES NOT CONTAIN 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 EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI STANDARD LAPAROSCOPIC TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE." }, { "mdr_text_key": "25107027", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI RECEIVED MEDICAL RECORDS ON 11/07/2013 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THIS PATIENT UNDERWENT ELECTIVE ROBOTIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (BSO) ON (B)(6) 2008 FOR BRCA +, HX BREAST CANCER. SHE WAS NOTED TO HAVE THICK ADHESIONS IN THE MIDLINE OF THE UTERUS TO THE ABDOMINAL WALL. SHE HAS HAD 2 PRIOR LOW-TRANSVERSE C-SECTIONS. SHE WAS TAKING TAMOXIFEN 25 MG DAILY. HER OPERATION WENT SMOOTHLY WITHOUT INCIDENT OR COMPLICATION. PRE-OPERATIVE RECORDS WERE OBTAINED DOCUMENTING THE PATIENT'S MEDICAL HISTORY. SHE WAS A NON-SMOKER. A PATHOLOGY REPORT WAS RECEIVED. FOUR WEEKS AFTER HYSTERECTOMY THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND FEVER AND BEGAN TO SPONTANEOUSLY DRAIN WHAT APPEARED TO BE A VAGINAL CUFF ABSCESS OR AN INFECTED CUFF HEMATOMA. THIS IS CONSIDERED A MINOR COMPLICATION OF HYSTERECTOMY AND MAY OCCUR WITH ANY TYPE OF HYSTERECTOMY OPERATION. NO EVIDENCE OF VAGINAL CUFF DEHISCENCE WAS SEEN AND THE PATIENT DID NOT REQUIRE A SECOND OPERATION. NO FURTHER CLINICAL INFORMATION WAS 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": "11/13/2013" } ] }