{ "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": "2955842-2013-03148", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120821", "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": "20130823", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "410076", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI SI 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": "20250814", "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 SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "34 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Fever", "Unspecified Infection", "Chills", "Fluid Discharge" ] } ], "distributor_city": "", "date_report": "20131107", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305587", "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": "3587088", "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 RECEIVED INFORMATION INCLUDING MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 TO TREAT ENDOMETRIOSIS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY. THE PATIENT'S PROCEDURE WENT AS PLANNED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS DISCHARGED AND WAS READMITTED TO THE HOSPITAL ON (B)(6 )2012 WITH LOWER ABDOMINAL PAIN, CHILLS, FEVER AND BLOODY DISCHARGE. TEST RESULTS REVEALED THAT THE PATIENT HAD A VERY HIGH WHITE BLOOD CELL COUNT INDICATIVE OF INFECTION. THE PATENT'S PELVIC EXAM DEMONSTRATED A SLIGHT BLOODY DISCHARGE FROM THE VAGINA, NO PALPABLE PELVIC MASS WAS DETECTED. NO CLEAR SIGNS OF ABCESS AND INFECTION WERE REPORTED. THE PATIENT WAS STARTED ON IV ANTIBIOTICS AND REMAINED IN THE HOSPITAL FOR FIVE DAYS. SHE WAS DISCHARGED HOME ON ORAL AUGMENTIN AND FLAGYL. ON (B)(6) 2012 THE PATIENT DEVELOPED A FEVER OF 102. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR FURTHER MANAGEMENT. AT THE HOSPITAL SHE STAYED AFEBRILE, AND HAD LEUKOCYTOSIS OF 19.5 ON ADMISSION. THE PATIENT HAD A CT SCAN OF HER ABDOMEN AND PELVIS DONE WHICH SHOWED MARKED THICKENING OF THE RIGHT SIDED COLON AS WELL AS TRANSVERSE COLON. IT WAS NOTED THAT THERE WAS ALSO IRREGULAR FLUID COLLECTION ABOVE THE VAGINAL CUFF. THE PATIENT WAS STARTED ON IV CEFTAZIDIME, FLAGYL AND VANCOMYCIN, AN INFECTIOUS DISEASE CONSULT WAS CALLED TO SPEAK TO THE PATIENT WITH MANAGEMENT OF THE INFECTION AND ANTIBIOTICS." }, { "mdr_text_key": "11018240", "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 SI SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "25105229", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ISI HAS RECEIVED MEDICAL RECORDS FOR THE PATIENT'S ATTORNEY ON 11/07/2013.THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED IN THIS MEDICAL RECORD: THE PATIENT HAS A HISTORY OF BIPOLAR DISORDER AND BORDERLINE PERSONALITY DISORDER. THE PATIENT'S INITIAL HOSPITALIZATION AND SURGERY AFTER HYSTERECTOMY PRODUCED ONLY FLUID AND BLOOD AND NO PUS. THERE WAS NO REAL ABSCESS. THIS PATIENT DEVELOPED C. DIFICILE COLITIS ALSO KNOWN AS ANTIBIOTIC RELATED COLITIS.IT FREQUENTLY DEVELOPS AFTER ANTIBIOTIC ADMINISTRATION. THIS CAN HAPPEN WITH IV OR ORAL ANTIBIOTICS. 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" } ] }