{ "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": "2955842-2025-50158", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260105", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251210", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20260105", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "298873", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260105", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "430035", "catalog_number": "430035", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/04/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260105", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260625", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23959881", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251210", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "389191628", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PLASTIC PART OF THE TIP BROKE OFF, CAUSING THE MONOPOLAR CURVED SCISSORS (MCS) TIP TO DETACH. A FRAGMENT FELL INTO THE PATIENT AND THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BOTH THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND ITS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. DURING THIS INSPECTION, THE SURGICAL TEAM NOTED THAT THE SCISSOR TIP WAS SOMEWHAT DIFFICULT TO INSTALL, WHICH WAS UNUSUAL. HOWEVER, NO OVERT PHYSICAL DAMAGE OR IRREGULARITIES WITH THE ACCESSORY OR INSTRUMENT WERE OBSERVED AT THAT TIME. DURING THE PROCEDURE, THE SCISSOR INSTRUMENT WAS USED FOR DISSECTION. AT SOME POINT, THE MCS TIP COVER ACCESSORY/INSTRUMENT TIP FELL INSIDE THE PATIENT. THE TEAM WAS ABLE TO RETRIEVE THE TIP WITH THE AID OF THE INSTRUMENT. WHEN ASKED WHAT MAY HAVE CAUSED THE TIP TO SLIP OFF OR BREAK, THERE WAS NO SPECIFIC INFORMATION PROVIDED BY THE SURGEON. HOWEVER, IT WAS OBSERVED DURING THE CASE THAT THE TIP WAS SEATED CROOKEDLY. THE INSTRUMENT WAS USED FROM THE BEGINNING OF THE OPERATION UNTIL THE INCIDENT OCCURRED. THROUGHOUT THE PROCEDURE, NO COLLISIONS WITH OTHER INSTRUMENTS WERE REPORTED, AND THE INSTALLATION TOOL WAS NOT USED FOR THE TIP COVER. ADDITIONALLY, NO REDUCER WAS REQUIRED SINCE THE PROCEDURE WAS PERFORMED USING A SINGLE PORT (SP) APPROACH, AND NO ELECTROLUBE OR LUBRICANT WAS APPLIED PRIOR TO TIP COVER APPLICATION. REMOVAL OF THE INSTRUMENT AND ACCESSORY WAS UNEVENTFUL¿THERE WAS NO RESISTANCE OR DIFFICULTY REPORTED, AND THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL, ADHERING TO BEST PRACTICE FOR MINIMIZING RISK OF DAMAGE. AFTER THE EVENT, THE SURGICAL STAFF NOTICED DAMAGE ON THE MCS INSTRUMENT ITSELF, BUT NO DAMAGE WAS NOTED ON THE TIP COVER ACCESSORY OR THE CANNULA. THE OPERATION WAS COMPLETED ROBOTICALLY USING A NEW PAIR OF SCISSORS AFTER THE INCIDENT. BOTH THE MCS TIP COVER ACCESSORY AND THE MCS INSTRUMENT INVOLVED IN THE EVENT WERE SENT BACK TO INTUITIVE SURGICAL (ISI) FOR FURTHER EVALUATION, AS IS STANDARD FOLLOWING SUCH OCCURRENCES." }, { "mdr_text_key": "389191629", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "407798727", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE PORT (SP), 6MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN INSTRUMENT TUBE ADAPTER. THIS COMPONENT IS LOCATED AT THE DISTAL END OF THE INSTRUMENT AND SERVES AS THE INTERFACE BETWEEN THE INSTRUMENT AND THE USER INSTALLED TIP ACCESSORY. THE BROKEN PIECE WAS NOT RETURNED AND MEASURES APPROXIMATELY 3.14MM X 1.85MM IN SIZE. ADDITIONAL OBSERVATION: DUE TO THE BROKEN TUBE ADAPTER, A DETACHED FRAGMENT WAS OBSERVED THAT WAS NOT RETURNED WITH THE INSTRUMENT." }, { "mdr_text_key": "407798728", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO 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": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/25/2026" } ] }