{ "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": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2022-11549", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220510", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220411", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220510", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20191023", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1069029", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220510", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380601-34", "catalog_number": "380601", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20220510", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "77 YR", "patient_sex": "Female", "patient_weight": "104 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220411", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14346592", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220411", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "291310749", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CAN BE ATTRIBUTED TO SCANLAN BULLDOG CLAMPS (A 3RD-PARTY MANUFACTURER PRODUCT). THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. THERE WERE NO ERRORS OBSERVED DURING THE PROCEDURE THAT MAY BE ASSOCIATED WITH ISSUES WHEN APPLYING A BULLDOG CLAMP. ISI RECEIVED A VIDEO CLIP RELATED TO THE ALLEGED COMPLAINT. A REVIEW OF THE VIDEO CLIP WAS CONDUCTED BY AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE). ON (B)(6) 2022, THE SURGEON PERFORMED A RETROPERITONEAL PARTIAL NEPHRECTOMY. BLOOD WAS PRESENT IN THE DISSECTION FIELD AND A BLOOD-SOAKED GAUZE IS REMOVED AND SUCTION IS PERFORMED. AFTER THE SP BULLDOG CLAMPS ARE APPLIED, FIREFLY IS TURNED ON AND THE FIELD APPEARS GREEN. THERE IS NOT SUFFICIENT EVIDENCE THAT THE BULLDOG CLAMPS DID NOT OCCLUDE THE ARTERY, SINCE IT IS LIKELY THAT THERE WAS STILL BLOOD OOZING IN THE FIELD WHICH WOULD FLUORESCE UNDER THE FIREFLY LASER. THERE MAY ALSO BE ADDITIONAL ARTERIES SUPPLYING THE KIDNEY AS WELL AS A VEIN THAT WAS NOT OCCLUDED THAT MAY ALLOW FOR BACKFLOW INTO THE KIDNEY. FIREFLY WAS NOT USED TO CHECK KIDNEY PERFUSION FOLLOWING THE REPLACEMENT OF THE SP BULLDOG CLAMPS WITH THE LAPAROSCOPIC BULLDOG CLAMP. BLOOD WAS OBSERVED DURING THE EXCISION OF THE RENAL MASS, WHICH FURTHER SUGGESTS THAT THE DISSECTION WAS ALREADY BLOODY EVEN WITH THE LAPAROSCOPIC BULLDOG CLAMP APPLIED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED RETROPERITONEAL PARTIAL NEPHRECTOMY, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY. AS A RESULT, THE SURGEON SWITCHED TO AN UNSPECIFIED LAPAROSCOPIC BULLDOG CLAMP AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THERE WAS NO BLEEDING OR INJURY SECONDARY TO THIS." }, { "mdr_text_key": "291310750", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RETROPERITONEAL PARTIAL NEPHRECTOMY, THE RENAL ARTERY WAS IDENTIFIED AND SKELETONIZED. THE SURGEON PLACED TWO SCANLAN BULLDOG CLAMPS (A 3RD-PARTY MANUFACTURER PRODUCT) ON THE RENAL ARTERY. FIREFLY WAS USED TO CONFIRM OCCLUSION OF THE ARTERY. HOWEVER, FIREFLY SHOWED THAT THE ARTERY WAS NOT PROPERLY OCCLUDED AND THE KIDNEY WAS STILL PERFUSED. AS A RESULT, THE SURGEON REMOVED THE SCANLAN BULLDOG CLAMPS AND PLACED UNSPECIFIED LAPAROSCOPIC CLAMP(S). ON 25-APR-2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: DURING THE SURGICAL PROCEDURE, THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE SP FENESTRATED BIPOLAR INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE SCANLAN BULLDOG CLAMPS. THE SURGEON EXPLAINED THAT AFTER PROPER SKELETONIZATION, THE SP BULLDOG CLAMPS WERE APPLIED AND THEN FIREFLY WAS TURNED ON. THE FIELD APPEARED GREEN. THE SURGEON STATED THAT HE FELT THE CLAMPING FORCE WAS INADEQUATE. THE SURGEON SWITCHED TO UNSPECIFIED LAPAROSCOPIC BULLDOG CLAMP(S) TO CONTINUE THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THERE WAS NO ISSUE WITH ANY OF THE DA VINCI SP INSTRUMENTS AND NO INJURY OCCURRED. THE SURGEON NOTED THAT THE ISSUE WAS SPECIFIC TO TWO PARTICULAR LOT NUMBERS (1 AND 2) OF THE SCANLAN BULLDOG CLAMPS. HE HAS BEEN USING DIFFERENT LOT NUMBERS FOR THE SCANLAN BULLDOG CLAMPS SINCE THEN AND HAS NOT HAD ANY ISSUES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }