{ "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": "2955842-2014-05313", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20140828", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20130531", "reprocessed_and_reused_flag": "", "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": "20140829", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "527171", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20140828", "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": "0", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Failure to Fire" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250807", "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": "20140828", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "58 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Injury" ] } ], "distributor_city": "", "date_report": "20140802", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4045763", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20140802", "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": "4865630", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BSO FOR COMPLEX ADNEXAL MASS ON (B)(6) 2013. THE ATTORNEY REPRESENTING THE PATIENT ALLEGED THAT THE PATIENT SUFFERED AN UNSPECIFIED MISCELLANEOUS INJURY. THE PATIENT HAD DENSE ADHESIONS. APPARENTLY THERE WAS A MALFUNCTION OF A PK INSTRUMENT WHICH DID NOT ALLOW IT TO FIRE; HOWEVER, OTHER INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY EFFECT ON THE PROCEDURE OR THE PATIENT. NO MEDICAL RECORDS AFTER (B)(6) 2013 WERE PROVIDED." }, { "mdr_text_key": "12184837", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE PK DISSECTING FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSES OF THE REPORTED INSTRUMENT FAILURE AND THE PATIENT'S ALLEGED INJURY CANNOT BE DETERMINED. THE LOT OF THE INSTRUMENT IS UNKNOWN. IN ADDITION, DETAILS REGARDING THE PATIENT'S INJURY WERE NOT PROVIDED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT WAS INITIALLY REPORTED TO THE FDA VIA AN ALTERNATE SUMMARY REPORT SUBMITTED ON (B)(4) 2014 AS PART OF (B)(4). REFER TO MDR REPORT 2955842-2014-01197. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT'S ATTORNEY ALLEGED THAT A PK INSTRUMENT MALFUNCTIONED AND THE PATIENT EXPERIENCED A MISCELLANEOUS INJURY AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN." } ], "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": "09/02/2014" } ] }