{ "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": "2955842-2022-11949", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220531", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20220502", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220601", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210729", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "324109", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220531", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "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": "480440-05", "catalog_number": "480440", "lot_number": "L90210802 0229", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220511", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)230731(10)L90210802", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250801", "health_professional": "Y", "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": "20220531", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220502", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14556780", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220502", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "293346216", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FA FOUND THE PRIMARY FAILURE OF DISLODGED/MISSING JAW COVER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT JAW COVER WAS FOUND TO BE COMPLETELY REMOVED FROM THE DISTAL END. THE JAW COVER WAS NOT RETURNED WITH THE INSTRUMENT. THE PIVOT PINS AND WASHERS REMAINED INSTALLED ON THE INSTRUMENT AND DID NOT EXHIBIT ANY SIGNS OF PHYSICAL OR COSMETIC DAMAGE. NO CABLES OR WIRES WERE DAMAGED. THE JAWS DID NOT EXHIBIT ANY DAMAGE. A REVIEW OF THE LOGS FOUND NO FAILURES RELATED TO THE REPORTED INSTRUMENT. THE ROOT CAUSE FOR THE DISLODGED/MISSING JAW COVER IS ATTRIBUTED TO MISHANDLING/MISUSE. A REVIEW OF THE PROVIDED IMAGE WAS CONDUCTED AND IS CONSISTENT WITH THE ALLEGATION OF A GRAY PIECE FELL OFF THE SYNCHROSEAL INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. A REVIEW OF THE LOG SHOWED THE SYNCHROSEAL INSTRUMENT (PART# 480440-05 / LOTL# L90210802-0229) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE SYNCHROSEAL WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). FOR A RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY PROCEDURE. THIS IS A SINGLE USE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE INSTRUMENT BROKE AND A FRAGMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY." }, { "mdr_text_key": "293346217", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, A GRAY PIECE OF THE SYNCHOSEAL INSTRUMENT COMPLETELY FELL OFF INTO THE PATIENT. THE PIECE WAS REMOVED AND ANOTHER INSTRUMENT WAS USED AS A REPLACEMENT. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING INFORMATION FROM THE SURGEON: FOR THE LYMPHADENECTOMY PROSTATECTOMY PROCEDURE, ALL FRAGMENTS WERE RETRIEVED AND WAS CONFIRMED VISUALLY. NO ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON SUSPECTED THAT THE INSULATION WRAPPING SIMPLY HAD WEAR AND FELL OFF THE INSTRUMENT. THE SURGEON NOTED THAT THIS OCCURRED LESS THAN AN HOUR AFTER THE INSTRUMENT WAS FIRST USED. THE INSTRUMENT WORKED COMPLETELY FINE AND DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. THE INSTRUMENT WAS REMOVED IMMEDIATELY AFTER THE FRAGMENT FELL. IT WAS NOTED THAT THERE WAS NO RESISTANCE IN THE CANNULA, THE INSTRUMENT WRIST WAS STRAIGHTENED, NO DAMAGE TO THE CANNULA HAD OCCURRED, AND THERE WAS NO OTHER DAMAGE TO THE INSTRUMENT. THERE WAS NO PATIENT INJURY REPORTED AND NO POST-SURGICAL COMPLICATIONS. ON (B)(6) 2022, THE ISI CLINICAL SALES REPRESENTATIVE PROVIDED AN IMAGE OF THE SYNCHROSEAL INSTRUMENT." } ], "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": "" } ] }