{ "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": "2955842-2013-03052", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130815", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130712", "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": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130816", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "394703", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130815", "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 A6.0P8", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20130815", "sequence_number_treatment": [ "DA VINCI SI SURG SYS INSTRUMENTS, ACCESS & ESU." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20130716", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3290852", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130716", "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": "3605140", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHILE PERFORMING SUTURE, THE SURGEON SEWED INTO THE PATIENT'S BLADDER, WHICH CREATED A HOLE IN THE PATIENT'S BLADDER. THE PATIENT'S BLADDER WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. CONTACTED THE PHYSICIAN'S ASSISTANT (PA) THAT WAS ASSISTING DURING THE DA VINCI SURGICAL PROCEDURE. THE PA INDICATED THAT AFTER THE SURGEON HAD COMPLETED CLOSURE OF THE PATIENT'S VAGINAL CUFF AND AFTER THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT, A CYSTOSCOPY PERFORMED ON THE PATIENT FOUND THAT THE SURGEON HAD INADVERTENTLY SUTURED THE PATIENT'S BLADDER DURING CLOSURE OF THE PATIENT'S VAGINAL CUFF. THE DA VINCI SURGICAL SYSTEM WAS RE-DOCKED TO THE PATIENT AND THE SURGEON REMOVED THE SUTURE FROM THE PATIENT'S BLADDER AND RE-SUTURED THE PATIENT'S VAGINAL CUFF TO CORRECT THE MISPLACED SUTURE. NO REPAIR TO THE PATIENT'S BLADDER WAS REQUIRED. THE PA INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THAT INADVERTENT SUTURE OF THE PATIENT'S BLADDER BY THE SURGEON WAS DUE TO THE SURGEON'S TECHNIQUE. THE PA INDICATED THAT TO THE BEST OF HIS KNOWLEDGE, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "11008629", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE SITE, THE DA VINCI SURGICAL SYSTEM DID NOT MALFUNCTION IN A WAY THAT CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT; BUT WAS DUE TO THE SURGEON'S TECHNIQUE, WHILE SUTURING THE PATIENT'S VAGINAL CUFF. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT SUSTAINED A BLADDER INJURY DURING USE OF THE DA VINCI SURGICAL SYSTEM." } ], "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": "" } ] }