{ "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": "2955842-2014-02830", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140506", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140407", "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": "20140507", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "271631", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140506", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20140506", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Internal Organ Perforation" ] } ], "distributor_city": "", "date_report": "20140407", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3794447", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140407", "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": "4372128", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI BENIGN HYSTERECTOMY PROCEDURE, THE PATIENT'S BLADDER WAS PERFORATED. REPORTEDLY, THE DAMAGE TO THE PATIENT'S BLADDER WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. THE PATIENT'S BLADDER WAS REPAIRED USING THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER THE SURGEON HAD DIFFICULTY DELINEATING THE PATIENT'S TISSUE PLANES AND WHILE ATTEMPTING TO PERFORM THE COLPOTOMY PORTION OF THE HYSTERECTOMY PROCEDURE USING A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, THE SURGEON INADVERTENTLY PERFORATED THE PATIENT'S BLADDER WHILE CAUTERY ENERGY WAS ACTIVATED. THE DAMAGE TO THE PATIENT'S BLADDER WAS IMMEDIATELY RECOGNIZED BY THE SURGEON, AS THE SURGEON OBSERVED THAT THE INSTALLED CATHETER WAS VISIBLE. THE SURGEON REPAIRED THE DEFECT TO THE PATIENT'S BLADDER LAPAROSCOPICALLY USING THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED. AFTER THE 1ST REPAIR WAS COMPLETED, THE SURGEON OBSERVED LEAKAGE FROM THE REPAIRED AREA. THE SURGEON PERFORMED A 2ND REPAIR USING THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS ALSO SUTURED. ACCORDING TO THE CSR, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE SURGICAL PROCEDURE. IN ADDITION, ARCING FROM THE MCS INSTRUMENT WAS NOT OBSERVED DURING THE SURGICAL PROCEDURE. THE SURGEON COMPLETED THE PLANNED SURGICAL PROCEDURE USING THE DA VINCI SURGICAL SYSTEM. A CYSTOSCOPY WAS PERFORMED AT THE END OF THE SURGICAL PROCEDURE TO ENSURE THAT THE REPAIR WAS ADEQUATE. THERE WAS NO REPORT THAT THE PATIENT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT." }, { "mdr_text_key": "11778631", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE INITIAL REPORTER, IT HAS BEEN DETERMINED THAT THE INJURY TO THE PATIENT'S BLADDER WAS NOT CAUSED BY A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS CAUSED BY THE SURGEON'S DIFFICULTY DELINEATING THE PATIENT'S TISSUE PLANES DURING THE SURGICAL PROCEDURE. INTUITIVE SURGICAL, INC. HAS CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. AS OF THE DATE OF THE REPORT, NO RESPONSE HAS BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED AFTER THE EVALUATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED. 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: THE PATIENT SUSTAINED A BLADDER INJURY DURING A DA VINCI BENIGN HYSTERECTOMY PROCEDURE; HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USE ERROR." } ], "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": "" } ] }