{ "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": "2955842-2013-05396", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131122", "manufacturer_address_2": "", "pma_pmn_number": "K050369", "date_of_event": "20131023", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131125", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "608645", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131122", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250810", "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": "20131122", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20131023", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3484700", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20131023", "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": "11348918", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI, CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. THE CSR INDICATED THAT HE WAS TOLD BY THE SITE THAT, THE CASE WAS A REVISION OF A PREVIOUSLY PLACED MESH AND THAT THE MESH HAD SCARRED INTO THE PATIENT'S TISSUE EXTENSIVELY. REPORTEDLY, WHILE THE SURGEON WAS PULLING ON THE MESH, THE PATIENT BEGAN TO BLEED FROM A VESSEL THAT WAS ALSO SCARRED INTO THE MESH. THE AFFECTED VESSEL WAS PART OF AN UNUSUAL BRANCH OFF OF THE ILIAC OR THE MID-SACRAL VESSEL. THE CSR WAS TOLD BY THE SITE THAT THE SURGEON REPAIRED THE AFFECTED VESSEL USING 5-0 VYCRIL SUTURE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 300ML. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL PER THE SITE'S NORMAL PROTOCOLS. THE CSR INDICATED THAT THE SITE REPORTED THAT THE BLEEDING EXPERIENCED BY THE PATIENT WAS NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES, BUT WAS RELATED TO PATIENT ANATOMICAL ISSUES. ISI'S REVIEW OF THE SITE'S SYSTEM LOGS FOUND NO ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE DAMAGE TO THE PATIENT'S VESSEL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S VESSEL WAS DAMAGED DURING A DA VINCI SURGICAL PROCEDURE. BASED ON THE ADDITIONAL INFORMATION PROVIDED BY THE SITE, THE DAMAGE TO THE PATIENT'S VESSEL WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES, BUT, WAS RATHER RELATED TO THE PATIENT'S DIFFICULT ANATOMY." }, { "mdr_text_key": "4021041", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A MESH REVISION PROCEDURE USING THE DA VINCI SURGICAL SYSTEM, THE PATIENT EXPERIENCED BLEEDING FROM A VESSEL. THE AFFECTED VESSEL WAS REPAIRED INTRA-OPERATIVELY WITH THE DA VINCI SURGICAL SYSTEM. REPORTEDLY, THE SYSTEM WAS FUNCTIONING NORMALLY WHEN THE DAMAGE TO THE PATIENT'S VESSEL OCCURRED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED." } ], "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": "" } ] }