{ "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": "2955842-2021-10855", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210724", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20210629", "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": "WANG", "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": "20210724", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1119408", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210724", "brand_name": "DA VINCI", "generic_name": "MONOPOLAR CURVED SCISSORS (MCS) TIP", "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": "430035-10", "catalog_number": "430035", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/29/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210724", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "54 YR", "patient_sex": "Male", "patient_weight": "95 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210629", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12222749", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210629", "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": "263491756", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE IDENTIFIED THAT THE STAFF WAS OVER TIGHTENING THE TIPS AND THEN THE SURGEON WAS APPLYING SIDE WAYS PRESSURE CAUSING THE COUPLER TO BUCK AND THE TIP TO NOT STAY ATTACHED. ISI WILL NOT RECEIVE THE MONOPOLAR SCISSOR TIP FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE SITE. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE DETERMINED OR CONFIRMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE RELATED INSTRUMENT THAT WAS USED WITH THE MONOPOLAR SCISSOR TIP IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY OTHER COMPLAINTS FROM THE REPORTED EVENT. TWO PHOTOS HAVE BEEN RECEIVED FROM THE SITE, BUT AT THIS TIME, THERE IS INSUFFICIENT EVIDENCE TO COME TO ANY DEFINITIVE CONCLUSIONS REGARDING THE REPORTED EVENT WITHOUT THE PRODUCTS BEING RETURNED FOR FAILURE ANALYSIS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THE MONOPOLAR SCISSOR TIP WAS MISSING. THE TIP PIECE AND THE COUPLER HAD FALLEN INSIDE THE PATIENT AND WERE RETRIEVED DURING THE SAME PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME, OR INJURY. HOWEVER, UNINTENDED FRAGMENTS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION, CONTRIBUTING TO AN ADVERSE EVENT." }, { "mdr_text_key": "263491757", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON FOUND THE MONOPOLAR SCISSOR TIP WAS MISSING. THE CALLER FORWARDED A PICTURE SHOWING THAT THE TIP AND THE COUPLER WERE MISSING FROM THE MONOPOLAR SCISSOR. AT THE TIME OF THE CALL THE STAFF WAS UNABLE TO LOCATE THE COUPLER. THE STAFF REPLACED THE MONOPOLAR SCISSOR TIP AND WERE PROCEEDING WITH THE PROCEDURE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICES ENGINEER (TSE) EXPLAINED THE COUPLER IS RADIOLUCENT. THE REPORTER EXPLAINED SHE WOULD FOLLOW UP WITH ANY FURTHER DETAILS AS SHE RECEIVED THEM. THE TSE RECOMMENDED THE STAFF RMA THE MISSING MONOPOLAR SCISSOR TIP FOR FAILURE ANALYSIS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING INFORMATION ON 01-JULY-2021: THIS WAS A MONOPOLAR SCISSOR TIP SINGLE PORT (SP) INSTRUMENT SO IT WAS THE PLASTIC PORTION THAT GOES OVER THE SCREWS AND THE ACTUAL TIP THAT FELL IN THE PATIENT. THE PIECES WAS RETRIEVED AT THE END OF THE PROCEDURE. WE HAVE REQUESTED TO SEND BACK THE INSTRUMENT AND THE BROKEN PIECES BACK TO ISI. SHE WAS NOT IN THE PROCEDURE, BUT SAID THE ROBOTICS COORDINATOR WOULD BE A GOOD CONTACT PERSON THAT HELP WITH ANY ADDITIONAL QUESTIONS. ISI CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION ON 12-JULY-2021: THE FRAGMENTS THAT FELL INSIDE THE PATIENT HAVE ALREADY BEEN DISCARDED. SHE DID NOT KNOW WHERE THE INSTRUMENT WAS AT THE TIME (IT MIGHT HAVE BEEN DISCARDED ALREADY TOO). THERE HAS BEEN NO REPORTS OF ANY INJURY TO THE PATIENT POST PROCEDURE (FOR THIS INCIDENT)." }, { "mdr_text_key": "336637751", "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": "336637752", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." } ], "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": "05/24/2023" } ] }