{ "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": "2955842-2022-11144", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220419", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20220321", "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": "20220420", "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": "1271133", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220419", "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": "20250824", "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": "20220419", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20220321", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14153120", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220321", "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": "293562275", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION: THE SURGEON CLAIMED THAT THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY WHILE EXCISING TWO TUMORS ON THE INFERIOR AND SUPERIOR POLE OF THE KIDNEY. HE INITIALLY WORKED ON THE TUMOR ON THE INFERIOR POLE OF THE KIDNEY. THE SURGEON STATED THAT HE HAD SKELETONIZED THE RENAL ARTERY AND CLAMPED IT DOWN WITH THE SCANLAN BULLDOG CLAMP. HE MADE SURE HE CLAMPED IT WELL, AND THE TIP OF THE CLAMP WAS PAST THE ARTERY. HOWEVER, THE KIDNEY STILL WAS PERFUSED. AS A RESULT, THERE WAS AN ADDITIONAL 300CC OF BLOOD LOSS AND A POTENTIALLY HAZARDOUS DELAY IN THE PROCEDURE DURING WARM ISCHEMIA. THE TOTAL ISCHEMIA TIME AND THE ACTUAL EXTRA DELAY IN TIME WERE NOT PROVIDED. THE SURGEON THEN EXCISED THE TUMOR AND ADDRESSED THE BLEEDING WITH A FEW ADDITIONAL SUTURES. FOR THE SECOND TUMOR ON THE SUPERIOR POLE OF THE KIDNEY, THE SURGEON RECLAMPED THE RENAL ARTERY AGAIN WITH THE SCALAN BULLDOG CLAMP. HE CLAMPED APPROXIMATELY 4-5MM AWAY FROM THE INITIAL CLAMP WHEN HE REMOVED THE TUMOR FROM THE INFERIOR POLE. THIS TIME INDOCYANINE GREEN (ICG) WITH FIREFLY WAS USED, AND IT WAS FOUND THAT THE VESSEL, TUMOR, AND THE KIDNEY LIT UP, INDICATING IT WAS STILL PERFUSED. AS A RESULT, THE SURGEON SWITCHED FROM THE CURRENT SCANLAN BULLDOG CLAMP TO A LAPAROSCOPIC BULLDOG CLAMP AND COMPLETED THE PROCEDURE WITH NO FURTHER ISSUES. THE SURGEON CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE BIPOLAR ROBOTIC INSTRUMENT THAT WAS USED IN CONJUNCTION WITH THE BULLDOG CLAMPS. HE STATED THAT HE FELT THE CLAMPING FORCE WAS INADEQUATE, AND HE INFORMED THE SCANLAN MARKETING TEAM ABOUT IT. HE NOTED THAT THE PATIENT ALSO HAD A HISTORY OF HYPERTENSION, WHICH COULD HAVE RESULTED IN A THICKER VASCULAR WALL AND CONTRIBUTED TO THE REPORTED ISSUE." }, { "mdr_text_key": "293562276", "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 A THIRD PARTY MANUFACTURER PRODUCT (I.E. SCANLAN BULLDOG CLAMP). THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS OBTAINED, 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 SURGICAL APPLICATIONS ENGINEER AND THE FOLLOWING INFORMATION WAS PROVIDED. ON (B)(6) 2022 THE SURGEON PERFORMED A RIGHT DA VINCI-ASSISTED SP RETROPERITONEAL PARTIAL NEPHRECTOMY. THE PATIENT PRESENTED WITH TWO TUMORS ON HIS RIGHT KIDNEY ¿ A MORE ENDOPHYTIC TUMOR ON THE INFERIOR POLE AND A MORE EXOPHYTIC TUMOR ON THE SUPERIOR POLE. THE RETROPERITONEAL CAVITY WAS ACCESSED VIA A LARGE ACCESS PORT, WITH NO ADDITIONAL ASSISTING PORT. THE KIDNEY WAS IDENTIFIED, RENAL ARTERY SKELETONIZED, AND BOTH INFERIOR AND SUPERIOR TUMORS WERE EXPOSED AND CONFIRMED WITH A LAPAROSCOPIC ULTRASOUND PROBE. A SINGLE ARTERIAL SUPPLY WAS CONFIRMED FOR THE PATIENT¿S RIGHT KIDNEY VIA PRIOR CT SCAN AND MRI SCAN. PRIOR TO THE EXCISION OF THE INFERIOR TUMOR, TWO LP SCANLAN BULLDOGS WERE PLACED ON THE A PRIORI SKELETONIZED RENAL ARTERY USING THE SP FENESTRATED BIPOLAR FORCEPS ¿ THE LP BULLDOG CLAMPS APPEAR TO OCCLUDE THE FULL ARTERY AND DID NOT APPEAR TO FLUTTER. THE ENDS OF THE LP BULLDOG CLAMPS WERE NOT CLEARLY VISUALIZED DEEP TO THE RENAL ARTERY BUT THE SURGEON ENDORSED SEEING THEM ON THE OTHER SIDE OF THE ARTERY. THE TUMOR DISSECTION WAS CARRIED DEEP INTO THE KIDNEY DURING WHICH ARTERIAL BLEEDING WAS ENCOUNTERED. THE BEDSIDE WAS ABLE TO ASSIST THE SURGEON IN THE SUCTION OF THE BLOOD, BLEEDING WAS IDENTIFIED AND REPAIRED VIA SUTURING. THE INFERIOR DEFECT WAS THEN RECONSTRUCTED WITH ADDITIONAL SUTURING, TYPICAL FOR PARTIAL NEPHRECTOMY. THE LP CLAMPS WERE THEN REMOVED. THE SURGEON CONTINUED THE OPERATION, ADVANCING TO THE UPPER POLE TUMOR. THE LP BULLDOG CLAMPS WERE RE-PLACED ON THE RENAL ARTERY USING THE SP FENESTRATED BIPOLAR FORCEPS. ADDITIONAL ICG WAS INJECTED STATUS-POST RE-CLAMPING OF THE RENAL ARTERY, DEMONSTRATING THAT THE KIDNEY CONTINUED TO BE PERFUSED DESPITE LP CLAMP PLACEMENT. AT THIS POINT, THE LP CLAMPS WERE REMOVED AND A HAND-HELD APPLIED CLAMP WAS PLACED ON THE RENAL ARTERY. THE SUPERIOR TUMOR WAS SUCCESSFULLY EXCISED WITH NO ADDITIONAL UNEXPECTED BLOOD LOSS, SUPERIOR DEFECT WAS RECONSTRUCTED VIA SUTURING. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THE SCANLAN BULLDOG CLAMPS DID NOT SUFFICIENTLY OCCLUDE THE RENAL ARTERY RESULTING IN AN ADDITIONAL 300CC OF BLOOD LOSS AND A POTENTIALLY HAZARDOUS DELAY IN THE PROCEDURE DURING WARM ISCHEMIA. THERE WERE ADDITIONAL SUTURES PLACED TO ADDRESS THE BLEEDING. WHEN THE SAME ISSUE PERSISTED ON THE SECOND TUMOR, THE SURGEON SWITCHED TO A LAPAROSCOPIC BULLDOG CLAMP AND COMPLETED THE PROCEDURE." } ], "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": "" } ] }