{ "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": "2026-09-22", "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": "2955842-2014-03019", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20140515", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20140414", "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": "20140516", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "292258", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140515", "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": "20250805", "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": "20140515", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20140415", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3813962", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140415", "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": "11902767", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE PATIENT'S REPORTED INJURY CAN BE ATTRIBUTED TO USER-ERROR. PER THE INFORMATION PROVIDED BY THE SURGEON, THE PATIENT'S INJURY OCCURRED BECAUSE THE BEDSIDE ASSISTANT WAS PERFORMING ANOTHER TASK AND WAS NOT PAYING ATTENTION WHILE ADVANCING THE MCS INSTRUMENT INTO THE PATIENT. ACCORDING TO THE SURGEON, THE INJURY SUSTAINED BY THE PATIENT WAS UNRELATED TO ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE DA VINCI SI USER MANUAL SPECIFICALLY STATES: WARNING: THE INSTRUMENT MAY NOT BE IMMEDIATELY VISIBLE WHEN BEING MOVED FROM THE CANNULA INTO THE PATIENT. USE APPROPRIATE CAUTION WHEN MANUALLY INSERTING INSTRUMENTS INTO THE PATIENT. 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: DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S SEROSA WAS DAMAGED. HOWEVER, THE PATIENT'S INJURY CAN BE ATTRIBUTED TO USER-ERROR." }, { "mdr_text_key": "4398483", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT'S BOWEL WAS PUNCTURED WHILE ADVANCING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INTO THE PATIENT. REPORTEDLY, THE AFFECTED AREA WAS REPAIRED. ON (B)(4) 2014 INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THE PATIENT'S BOWEL WAS NOT PENETRATED; HOWEVER, THE SEROSA WAS DAMAGED. THE DEFECT WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. THE AFFECTED AREA WAS SUTURED AND NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. THE SURGEON INDICATED THAT THE BEDSIDE ASSISTANT WAS PERFORMING ANOTHER TASK AND WAS NOT PAYING ATTENTION WHILE THE MCS INSTRUMENT WAS BEING ADVANCED INTO THE PATIENT, THUS CAUSING DAMAGE TO THE PATIENT'S SEROSA. ACCORDING TO THE SURGEON, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, MCS INSTRUMENT OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AND IT IS HIS BELIEF THAT THE DEFECT TO THE PATIENT'S SEROSA WAS USE ERROR RELATED. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT RECOVERED WELL. THE SURGEON ALSO INDICATED THAT ONE WEEK POST THE SURGICAL PROCEDURE, THE PATIENT IS HEALING PERFECTLY 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": "" } ] }