{ "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": "2955842-2020-10561", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200611", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20200512", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "WANG", "source_type": [ "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20200611", "manufacturer_contact_f_name": "DAVID", "device_date_of_manufacturer": "20190125", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "610381", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200611", "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": "M10190130", "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": "00886874111048", "udi_public": "(01)00886874111048(17)210131(10)M10190130", "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": "05/13/2020", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250724", "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": "20200611", "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 Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200513", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "10146737", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200513", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "336759285", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336759286", "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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM \"PRODUCT PROBLEM\" TO \"ADVERSE EVENT AND PRODUCT PROBLEM\". B2 UPDATED TO \"REQUIRED INTERVENTION\". H1 UPDATED FROM \"MALFUNCTION\" TO \"SERIOUS INJURY\"." }, { "mdr_text_key": "233244984", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN. THE MCS TIP COVER ACCESSORY WAS DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR RETURN TO ISI FOR EVALUATION. ISI HAS ATTEMPTED TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: LARGE NEEDLE DRIVER (PART #470006-10; LOT #N10180126-0090) HAD ZERO LIVES REMAINING AT THE END OF THE PROCEDURE AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. AS OF 06/09/2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY HAS BEEN PERFORMED AND NO RELATED COMPLAINTS HAVE BEEN IDENTIFIED. THERE WERE NO IMAGES OR VIDEO RECORDING OF THE PROCEDURE FOR ISI TO REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, A MCS TIP COVER ACCESSORY ALLEGEDLY FELL OFF A MCS INSTRUMENT. HOWEVER, THERE IS NO EVIDENCE THAT A SERIOUS PATIENT INJURY OCCURRED SINCE THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE AFTER THE SURGEON ENLARGED AN EXISTING PORT SIZE INCISION. NO OPERATIVE COMPLICATIONS WERE REPORTED. AT THIS TIME, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN." }, { "mdr_text_key": "233244985", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY ALLEGEDLY FELL OFF UPON REMOVAL OF THE MCS INSTRUMENT. THE CUSTOMER CONFIRMED THAT THE TIP COVER ACCESSORY WAS FOUND UNDER THE SKIN WHEN A CT-SCAN WAS PERFORMED. THE SURGICAL STAFF WAS ABLE TO RETRIEVE THE TIP COVER ACCESSORY. A BACK-UP TIP COVER ACCESSORY WAS INSTALLED TO CONTINUE WITH THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED PATIENT INJURY OR HARM. THE TIP COVER ACCESSORY CANNOT BE ANALYZED AS THE SURGICAL STAFF DISCARDED THE ACCESSORY. ON 19-MAY-2020, THE CUSTOMER WAS CONTACTED AND THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT WAS OBTAINED: THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INTO THE PATIENT AS THE SURGICAL STAFF WAS REMOVING THE MCS INSTRUMENT. THE SURGEON NOTICED THAT THE TIP COVER ACCESSORY HAD FALLEN OFF ONE HOUR INTO THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE WERE NO INSTRUMENT COLLISIONS OBSERVED AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVING THE MCS INSTRUMENT THROUGH THE CANNULA. THE SURGEON ENSURED THAT THE WRIST OF THE MCS INSTRUMENT WAS STRAIGHTENED UPON REMOVAL AND THERE WAS NO DAMAGE FOUND ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. ACCORDING TO THE CUSTOMER, THE SURGEON MADE A SMALL INCISION ON UNSPECIFIED TISSUE AND REMOVED THE TIP COVER ACCESSORY. THE CUSTOMER EXPLAINED THAT THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED AT ALL TIMES DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY WAS NOT OVER-INSTALLED ON THE INSTRUMENT AS THE SURGICAL STAFF INDICATED THERE WAS NO ORANGE SURFACE VISIBLE ON THE MCS INSTRUMENT. THE CUSTOMER INSPECTED THE MCS TIP COVER ACCESSORY PRIOR TO USE AND FOUND NO ISSUES. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE. THE MCS TIP COVER ACCESSORY CANNOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED FOLLOWING THE PROCEDURE. ON 09-JUN-2020, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IN REGARDS TO THE SMALL INCISION THAT WAS MADE, THE SURGEON ENLARGED AN EXISTING PORT SITE INCISION IN ORDER TO REMOVE THE MCS TIP COVER ACCESSORY. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT¿S CURRENT STATUS WAS NOTED AS ¿GOOD.¿" } ], "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": "05/24/2023" } ] }