{ "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": "2955842-2013-03135", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130823", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20110819", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "HEALTH PROFESSIONAL", "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": "409703", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130823", "brand_name": "DA VINCI S 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": "IS2000 A5.PP8", "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": "20250804", "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": "45 YR", "patient_sex": "", "patient_weight": "71", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Abdominal Pain", "Abscess" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3305514", "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": "18253787", "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 LIMITED MEDICAL RECORDS, OF A PATIENT WHO DEVELOPED POST- SURGICAL COMPLICATIONS AFTER HAVING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011 FOR MENORRHAGIA AND FIBROID UTERUS. THE PATIENT'S POST OPERATIVE RECOVERY WAS UNEVENTFUL AND SHE WAS DISCHARGED THE NEXT DAY AFTER HAVING THE DA VINCI PROCEDURE. NO ADDITIONAL OPERATIVE INFORMATION WAS PROVIDED. PATIENT RETURNED TO THE HOSPITAL (B)(6) 2011 AFTER BILATERAL LOWER ABDOMINAL PAIN AND WAS FOUND TO HAVE PELVIC ABSCESS WITH AN ABDOMINAL CT. SHE HAD A WASH OUT ON (B)(6) 2011. SHE REMAINED AFEBRILE, HOWEVER CONTINUED WITH LEUKOCYTOSIS. THERE WAS NO CHANGE IN ABSCESSES ON REPEAT CT SCAN ON (B)(6) 2011. ON (B)(6) 2011, PATIENT HAD DIAGNOSTIC LAPAROSCOPY CONVERTED TO AN EXPLORATORY LAPAROTOMY AND REPEAT WASHOUT. A WOUND VAC AND JP DRAIN WAS PLACED AFTER THIS, WHICH WAS REMOVED 3 DAYS LATER, AND 5 DAYS LATER, AND THE PATIENT'S ABDOMINAL WOUND CLOSED. THE PATIENT'S SYMPTOMS CONTINUED TO IMPROVE. THE PATIENT WAS DISCHARGED (B)(6) 2011 WITHOUT ADDITIONAL ANTIBIOTICS. DURING HER POST OPERATIVE SCHEDULED FOLLOW UP, THE PATIENT WAS NOTED TO BE DOING WELL. THE PATIENT WAS DOING WELL; HOWEVER HAD COMPLAINTS OF FEELING COLD AND DECREASED APPETITE. THE PATIENT WAS ADVISED TO RETURN BACK TO THE HOSPITAL. PATIENT WAS STARTED ON LEVOFLOXACIN. CT GUIDED DRAINAGE WAS ATTEMPTED, BUT UNSUCCESSFUL. REPEAT CT SCANS SHOW SOME IMPROVEMENT IN PATIENT'S PELVIC ABSCESSES. AS THE SURGICAL OPTIONS WERE NOT FELT TO BE OPTIMAL, THE PATIENT CONTINUED ON AVELOX FOR THERAPY. THE PATIENT REPORTED NOT TO HAVE UNDERGONE A FOLLOW UP CT SCAN. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PROCEDURE. AT THIS TIME THERE IS NO INFORMATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY OCCURRED AT THE TIME OF THE PROCEDURE." }, { "mdr_text_key": "18434524", "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 SURGICAL HYSTERECTOMY PROCEDURE." } ], "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": "" } ] }