{ "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": "2955842-2025-00698", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250123", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20241226", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250123", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240111", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2550260", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250123", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-14", "catalog_number": "400180", "lot_number": "L83240111", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250122", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(17)260131(10)L83240111", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/24/2025;03/27/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250826", "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": "20250123", "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", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241230", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21225776", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241230", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "362032000", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE EVENT INVESTIGATION IS IN PROGRESS." }, { "mdr_text_key": "362032001", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FRAGMENT FROM THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT. THE FRAGMENT(S) WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE SURGEON WAS ABLE TO USE A BACKUP MCS TIP COVER ACCESSORY TO COMPLETE THE PROCEDURE ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE CLEAR AREA OF THE MCS TIP COVER ACCESSORY WAS SEPARATED FROM THE GRAY AREA. NO ARCING WAS OBSERVED." }, { "mdr_text_key": "368823528", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "368823529", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FURTHER FAILURE ANALYSIS (FA) INVESTIGATION WAS PERFORMED FOR ONE OF THE THREE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORIES THAT WERE RETURNED. THE INITIAL FA WAS CONFIRMED. THE CLEAR SILICONE PORTION OF THE TIP COVER ACCESSORY WAS FOUND TO BE CLEANLY SEPARATED FROM THE GREY PELLATHANE MATERIAL OF THE ACCESSORY. THE ACCESSORY WAS RETURNED WITH THE PELLATHANE INSERT COMPLETELY SEPARATED FROM THE SILICONE OVERMOLD. THE GRAY PELLATHANE DID NOT APPEAR TO HAVE ANY RESIDUAL SILICONE ON IT, AND THE SILICONE OVERMOLD DID NOT APPEAR TO EXHIBIT ANY SIGNS OF PHYSICAL DAMAGE. THE SILICONE OVERMOLD ALSO DID NOT CARRY ANY OF THE GRAY PELLATHANE, AND IT APPEARS THE SEPARATION BETWEEN THE TWO COMPONENTS WAS VERY CLEAN. THE ACCESSORY APPEARS TO HAVE BEEN REPROCESSED WHICH CAN CAUSE SHRINKAGE OF THE PELLATHANE MATERIAL. THE GREY PELLATHANE COMPONENT OF THE ACCESSORY WAS MEASURED FOR LENGTH AND WAS FOUND TO BE 1.5995 INCHES. THE COMPONENT HAS A SPECIFIED LOWER LIMIT OF 1.610 INCHES WHICH THIS ACCESSORY WAS FOUND TO BE LESS THAN. ADDITIONALLY, THE SILICONE PORTION WAS ABLE TO BE EASILY PLACED OVER THE GREY PELLATHANE PORTION AND EASILY REMOVED. ADDITIONALLY, FURTHER FA INVESTIGATION WAS PERFORMED FOR ANOTHER MCS TIP COVER ACCESSORY THAT WAS RETURNED. THE INITIAL FA WAS CONFIRMED. THE CLEAR SILICONE PORTION OF THE TIP COVER ACCESSORY WAS FOUND TO BE CLEANLY SEPARATED FROM THE GREY PELLATHANE MATERIAL OF THE ACCESSORY. THE ACCESSORY WAS RETURNED WITH THE PELLATHANE INSERT COMPLETELY SEPARATED FROM THE SILICONE OVERMOLD. THE GRAY PELLATHANE DID NOT APPEAR TO HAVE ANY RESIDUAL SILICONE ON IT, AND THE SILICONE OVERMOLD DID NOT APPEAR TO EXHIBIT ANY SIGNS OF PHYSICAL DAMAGE. THE SILICONE OVERMOLD ALSO DID NOT CARRY ANY OF THE GRAY PELLATHANE, AND IT APPEARS THE SEPARATION BETWEEN THE TWO COMPONENTS WAS VERY CLEAN. THE ACCESSORY APPEARS TO HAVE BEEN REPROCESSED WHICH CAN CAUSE SHRINKAGE OF THE PELLATHANE MATERIAL. THE GREY PELLATHANE COMPONENT OF THE ACCESSORY WAS MEASURED FOR LENGTH AND WAS FOUND TO BE 1.6085 INCHES. THE COMPONENT HAS A SPECIFIED LOWER LIMIT OF 1.610 INCHES WHICH THIS ACCESSORY WAS FOUND TO BE LESS THAN. ADDITIONALLY, THE SILICONE PORTION WAS ABLE TO BE EASILY PLACED OVER THE GREY PELLATHANE PORTION AND EASILY REMOVED. THE MCS TIP COVER ACCESSORY IS A SINGLE-USE DEVICE AND IS NOT TO BE REPROCESSED. PELLATHANE IS TYPICALLY INCOMPATIBLE WITH AUTOCLAVING AND CAN WARP AND/OR SHRINK WHEN EXPOSED TO HIGH TEMPERATURES. THE CLEAN SEPARATION BETWEEN THE INSERT AND OVERMOLD COULD POTENTIALLY BE CAUSED BY SHRINKAGE OF THE PELLATHANE INSERT." }, { "mdr_text_key": "364473130", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THREE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORIES TO PERFORM FAILURE ANALYSIS. ONE TIP COVER WAS ANALYZED AND FOUND TO BE TORN AND SEPARATED. THE TIP COVER WAS FOUND TO HAVE TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT. THE TIP COVER WAS FOUND TO HAVE THE CLEAR TIP SEPARATED FROM THE GREY END. THE TEARS ARE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURE FROM 0.018¿ TO 0.118¿ IN LENGTH. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE MCS INSTRUMENT REQUIRES THE USE OF A TIP COVER TO PREVENT ENERGY FROM DISCHARGING ANYWHERE BUT AT THE INSTRUMENT¿S TIP. THE SECOND TIP COVER WAS FOUND TO HAVE THE CLEAR TIP SEPARATED FROM THE GREY END. THERE WERE NO TEARS. THERE WERE NO SIGNS OF THERMAL DAMAGE. DAMAGE TO TIP COVERS IS ATTRIBUTED TO EITHER IMPROPER INSTALLATION ONTO THE MCS INSTRUMENT OR EXPOSURE TO REPEATED THERMAL AND MECHANICAL STRESSES DURING NORMAL USE CONDITIONS OR COLLISIONS THAT CAN LEAD TO EXCESSIVE WEAR RESULTING IN TEARS. THE THIRD TIP COVER WAS FOUND TO HAVE THE CLEAR TIP SEPARATED FROM THE GREY END. THERE WERE NO SIGNS OF THERMAL DAMAGE. THE UNIT IS AN ACCESSORY AND DOES NOT GET CAPTURED BY INSTRUMENT LOGS. THEREFORE, AN INSTRUMENT LOG REVIEW OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE(S) INVOLVED WITH THE REPORTED EVENT HAS BEEN COMPLETED. NO NON-CONFORMANCES WERE IDENTIFIED TO BE RELATED TO THIS COMPLAINT. THE PROBABLE ROOT CAUSE OF A DAMAGED TIP COVER IS ATTRIBUTED TO EITHER IMPROPER INSTALLATION ONTO THE MCS INSTRUMENT OR OTHER INSTRUMENTS RUBBING AGAINST IT DURING NORMAL USE CONDITIONS OR COLLISIONS. THESE STRESSES CAN LEAD TO EXCESSIVE WEAR RESULTING IN SMALL BREAKS OR SPLITS. TEARING OF THE TIP COVER DISTAL TO THE MCS BLADES WOULD BE ADJACENT TO THE ACTIVE ELECTRODE OF THE MCS INSTRUMENT, WHICH IS CAREFULLY CONTROLLED BY THE SURGEON AND UNDER CONSTANT OBSERVATION WHILE CAUTERY IS APPLIED TO TISSUE. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE TIP COVER ACCESSORY TO COMPLETE THE PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "02/21/2025;04/23/2025" } ] }