{ "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": "2955842-2013-03195", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130826", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20120822", "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": "20130826", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "416669", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130826", "brand_name": "DA VINCI S 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": "IS 2000 A5.1P8", "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": [ "Leak/Splash" ], "reporter_state_code": "IL", "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": "20130826", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "32 YR", "patient_sex": "", "patient_weight": "65", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Edema", "Swelling", "Injury", "Dysuria" ] } ], "distributor_city": "", "date_report": "20130725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3306694", "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": "18100169", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) 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. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2012 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL HYSTERECTOMY PROCEDURE." }, { "mdr_text_key": "17949052", "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 UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR EXCESSIVE CRAMPING AND HEAVY BLEEDING. THE PATIENT HAD BEEN EXPERIENCING VAGINAL BLEEDING SINCE THE BIRTH OF HER CHILD IN 2001. IN 2008, THE PATIENT HAD AN ABLATION OF THE UTERUS TO HELP STOP THE BLEEDING BUT THE HEAVY BLEEDING PERSISTED. THE PATIENT OPTED FOR A HYSTERECTOMY. THE PATIENT WAS INFORMED THAT BECAUSE OF HER HISTORY OF 3 CESAREAN SECTIONS, HER BLADDER MAY POSSIBLY TEAR DURING THE SURGICAL PROCEDURE IF IT WAS ADHERING TO HER UTERUS. ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY, LYSIS OF ADHESIONS AND CYSTOSCOPY PROCEDURE. ADHESIONS WERE NOTED OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL INFERIOR TO THE UMBILICUS. THE ADHESIONS WERE LYSED. THERE WERE ALSO SIGNIFICANT ADHESIONS OF THE BLADDER TO THE UNDERLYING CERVIX AND LOWER UTERINE SEGMENT. IT WAS ALSO NOTED THAT THERE WAS NO ENTRAPMENT OF ABDOMINAL CONTENTS NOTED AT UMBILICAL DEFECT FASCIAL CLOSURE. DURING THE PROCEDURE, ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED A LEFT INGUINAL HERNIA AS C02 GAS FILLED THE LEFT VULVA DURING THE PROCEDURE. THE SWELLING RESOLVED FOLLOWING SURGERY. A CYSTOSCOPY DID NOT REVEAL ANY BLADDER INJURY. THE PATIENT WOKE UP HAPPY AND WAS DISCHARGED AT 6PM THE SAME DAY. ON (B)(6) 2012, THE PATIENT REPORTED TROUBLE URINATING. THE FOLLOWING DAY, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) DUE TO SWELLING TO LEFT LOWER ABDOMEN NEAR ONE OF THE SURGICAL SITES AND LABIA. A CT SCAN OF HER ABDOMEN/PELVIS SHOWED EXTENSIVE AIR AND EDEMA WITHIN THE SUBCUTANEOUS TISSUE CONSISTENT WITH SUBCUTANEOUS EMPHYSEMA. ON (B)(6) 2012, A CYSTOGRAM WAS PERFORMED WHICH SHOWED THERE WAS A CONTAINED LEAK FROM THE FUNDUS OF THE URINARY BLADDER. ON (B)(6) 2012, THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE TO REPAIR THE RIGHT POSTERIOR BLADDER INJURY. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. A FOLLOW UP VISIT ON (B)(6) 2012 INDICATED THAT THE PATIENT WAS GENERALLY RECOVERING WELL." } ], "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": "" } ] }