{ "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": "2955842-2021-10815", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20210719", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20210621", "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": "WANG", "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": "20210719", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20201001", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1089480", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210719", "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": "T90201001 0068", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210721", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)221031(10)T90201001", "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", "Device Dislodged or Dislocated", "Detachment of Device or Device Component", "Device Dislodged or Dislocated" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/22/2021;06/21/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20210719", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " 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": "20210621", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12187016", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210621", "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": "335839495", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335839496", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED." }, { "mdr_text_key": "326076462", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: D9, G3, G6, H2, H3, H6, AND H10. D03 - INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SYCHROSEAL INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS (FA) INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT OF \"SYNCHROSEAL PIVOT PIN WASHER DETACHED FROM THE INSTRUMENT\". FOR CLARIFICATION, THE INSTRUMENT PIVOT PIN WASHER WAS NO LONGER ATTACHED TO THE JAW COVER AT THE WRIST ASSEMBLY. MATERIAL APPROXIMATELY 0.11\" X 0.03\" WAS MISSING AND WAS NOT RETURNED BY THE CUSTOMER. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISLODGED WASHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE ROOT CAUSE WAS ATTRIBUTED TO MISHANDLING/MISUSE. ADVANCED FA (AFA) PERFORMED ADDITIONAL EVALUATION OF THE INSTRUMENT AND IDENTIFIED THE FOLLOWING: AFA CONFIRMED THE INITIAL FA FINDINGS AND FOUND THE PIVOT PIN WASHER DISLODGED FROM HE INSTRUMENT ON THE SWAGED END. THE PIVOT PIN WASHER WAS NOT RETURNED WITH THE INSTRUMENT, THEREFORE IT COULD NOT BE INSPECTED FOR DAMAGE. THE PIVOT PIN APPEARED TO BE SWAGED, BUT THE SWAGE APPEARED LOPSIDED. THE PIVOT PIN WAS SECURE WITHIN THE INSTRUMENT AND THERE WAS NO DAMAGE FOUND ON THE PIVOT PIN OR JAW COVER SURROUNDING THE WASHER LOCATION. THE ROOT CAUSE OF THIS FINDING WAS ATTRIBUTED TO MANUFACTURING." }, { "mdr_text_key": "326076463", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "262153602", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SYCHROSEAL INSTRUMENT HAS NOT YET BEEN RECEIVED FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A REVIEW OF THE INSTRUMENT LOG FOR THE SYCHROSEAL INSTRUMENT PART#480440-05/ T90201001 0068 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 ON SYSTEM SK1735. THERE WERE 0 USES REMAINING. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: ALL FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, UNINTENDED FRAGMENTS FALLING INTO THE PATIENT MAY REQUIRE SURGICAL INTERVENTION. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE REPORTED EVENT TO OCCUR. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. IMPLANT DATE (2020 REPORTS) IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN INITIAL REPORTER NAME AND ADDRESS IS NOT AVAILABLE. FIELDS PMA/510K (2020 REPORTS), ADVERSE EVENT, RECALL (IF RECALL NUMBER IS GIVEN) (2020 REPORTS) AND CORRECTION/REMOVAL NUMBER (2020 REPORTS) ARE NOT APPLICABLE." }, { "mdr_text_key": "262153603", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY SURGICAL PROCEDURE, THE PIVOT PIN WASHER FROM THE SYNCHROSEAL INSTRUMENT WAS FOUND IN THE PATIENT NEAR LEFT PELVIC LYMPH NODES (JUST LATERAL OF THE PROSTATE) AND THEN IT WAS NOTICED THAT IT WAS MISSING FROM THE INSTRUMENT. IT WAS NOTED BY THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REP (CSR), WHO WAS PRESENT FOR THE CASE, THAT THE JAWS STARTED OPENING WIDER THAN EXPECTED (E.G. RUBBER THAT ALLOWS JAWS TO OPEN NEAR THE WRIST ALLOWED FOR GREATER JAW OPENING THAN OTHER SYNCHROSEAL INSTRUMENTS). SEALING AND SYNCH FUNCTIONALITY WAS NOTED TO BE COMPLETELY NORMAL. NO ARCING OR ANY ABNORMALITIES WITH ENERGY ACTIVATION WERE NOTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY BY USING A BACKUP INSTRUMENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER ON 16-JUL-2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ALL FRAGMENTS WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER AND IT WAS CONFIRMED BY THE PHYSICIAN AND THE ISI REP THAT THE WASHER WAS TAKEN OUT IN WHOLE. THERE WAS NO ADDITIONAL SURGICAL PROCEDURE OR POST-OPERATIVE TESTS REQUIRED. THE SURGEON DOES NOT NOW KNOW WHAT CAUSED THE INSTRUMENT TO BREAK. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 10 MINUTES PRIOR TO THE ISSUE. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE FOUND. A DISSECTION WAS BEING PERFORMED WHEN THE ISSUE OCCURRED AND IT WAS NOTED THAT THE JAWS OPENED WIDER THAN THEY TYPICALLY SHOULD. THERE WERE NO INSTRUMENT COLLISIONS AND THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL, THE WRIST WAS STRAIGHTENED, AND THE STAFF DID NOT NOTICE ANY RESISTANCE OR DAMAGE WHEN REMOVING INSTRUMENT FROM THE CANNULA. THERE WAS NO PATIENT INJURY AND THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATING TO THE EVENT. THE DEVICE HAS BEEN SENT BACK FOR EVALUATION. NO ADDITIONAL PATIENT-RELATED INFORMATION COULD BE PROVIDED." } ], "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": "08/20/2021;05/24/2023" } ] }