{ "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": "2955842-2023-10702", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230216", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20230118", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20230216", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211117", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "354874", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230216", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470056-08", "catalog_number": "470056", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230131", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874116562", "udi_public": "(01)00886874116562", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Noise, Audible", "Noise, Audible" ], "reporter_state_code": "", "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": "20230216", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230118", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16385897", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230118", "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": "309655778", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY PROCEDURE, THE PATIENT'S VAS DEFERENS WAS INJURED. THE ISSUE OCCURRED DURING THE END OF THE PROCEDURE WHILE PERFORMING THE ANASTOMOSIS. THE SURGEON ROTATED THE 0 DEGREE ENDOSCOPE PLUS SEVERAL TIMES WHILE LOOKING FOR A SUTURE NEEDLE, AFTER WHICH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT ALLEGEDLY WENT OUT OF CONTROL TOWARDS THE VAS DEFERENS AND UNINTENTIONALLY TRANSECTED IT. IT IS UNCLEAR IF THE VAS DEFERENS WAS REPAIRED. THE ARTERY AND VEIN NEXT TO THE VAS DEFERENS DID NOT CONTACT THE MCS AND WERE THEREFORE NOT INJURED. WHILE ROTATING THE ENDOSCOPE, AN UNSPECIFIED ¿BAD SOUND¿ WAS HEARD. NO ERROR MESSAGE DISPLAYED. ALL THE INSTRUMENTS WERE THEN REMOVED FROM THEIR RESPECTIVE UNIVERSAL SURGICAL MANIPULATORS (USM)S AND REINSTALLED. THE SURGICAL STAFF THEN CONTINUED THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN 8MM 30 DEGREE ENDOSCOPE. THE SURGEON BELIEVES THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION WAS DUE TO A PROBLEM WITH THE 0 DEGREE ENDOSCOPE PLUS FOLLOWED BY FEELING UNEXPECTED MOVEMENTS WITH THE USMS. THE PATIENT DID NOT EXPERIENCE POST-OPERATIVE COMPLICATIONS AND WAS REPORTED TO BE ¿OKAY¿. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) VIEWED THE SYSTEM ERROR LOGS AND FOUND NO RELEVANT ERRORS." }, { "mdr_text_key": "309655779", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. AN ISI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE, REVIEWED ERROR LOGS, AND VERIFIED SYSTEM TO BE READY FOR USE. ALTHOUGH THE FSE WAS UNABLE TO REPLICATE OR REPRODUCE THE CUSTOMER REPORTED MANIPULATOR ISSUE, THE PATIENT SIDE CART (PSC) CARD CAGE WAS REPLACED. ISI HAS RECEIVED THE 0 DEGREE ENDOSCOPE PLUS ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF A ¿BAD SOUND¿ AND NOTED THE FOLLOWING ISSUES: DAMAGED/FRICTION ISSUE, DAMAGED CABLE INTEGRITY, AND DISCOLORATION OF HOUSING. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW WAS PERFORMED FOR THIS PROCEDURE: NO RELEVANT ERRORS WERE OBSERVED DURING THIS PROCEDURE. AN ADVANCED INSTRUMENT LOG REVIEW ON THE MCS INSTRUMENT WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAILURE ANALYSIS ENGINEER (FAE). PER THE FAE, IT APPEARS THAT THERE IS A POTENTIALLY RELATED ERROR TO THE REPORTED COMPLAINT WHICH STATES ¿A SURGEON¿S HAND MAY NOT HAVE BEEN TOUCHING THE RIGHT MTM WHILE IN FOLLOWING MODE AT SSC1¿ (SURGEON SIDE CONSOLE). THIS INDICATES THAT THE SYSTEM HAS DETECTED CONDITIONS CONSISTENT WITH THE MASTER TOOL MANIPULATOR (MTM) MOVING IN FOLLOWING WITHOUT THE SURGEON¿S HANDS ON THE HANDLE. AN ADVANCED LOG REVIEW ON THE USMS WAS PERFORMED FOR THIS PROCEDURE BY AN ISI ADVANCED FAE. PER THE FAE, THERE IS NOTHING IN THE LOGS THAT WOULD SUGGEST ANYTHING WRONG WITH THE SYSTEM THAT MAY HAVE CAUSED THE NON-INTUITIVE MOTION. THERE WERE NO ERRORS ON ARM [USM] 4, THE ARM THAT THE MCS INSTRUMENT WAS INSTALLED ON. THE ENDOSCOPE WAS INSTALLED ON ARM 3 WHICH DID HAVE A FEW ENGAGEMENT FAILURES. THIS ARM HAS NOT EXPERIENCED ANY ENGAGEMENT ERRORS SINCE THAT PROCEDURE, SO IT WAS LIKELY A SEATING ISSUE OR SOMETHING WRONG WITH THE ENDOSCOPE CAUSING THE ENGAGEMENT FAILURES. TO BE CLEAR, AN ENGAGEMENT FAILURE DOES NOT CONFIRM THE NON-INTUITIVE MOTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT¿S VAS DEFERENS WAS INJURED. THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN. NOTE: REFER TO THE MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE REPORTED EVENT LOGGED AGAINST THE MCS INSTRUMENT. NOTE: REFER TO THE MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER #(B)(6) FOR MDR SUBMISSION OF THE REPORTED EVENT LOGGED AGAINST THE PSC." } ], "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": "" } ] }