{ "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": "2955842-2021-10982", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210824", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210729", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20210824", "manufacturer_contact_f_name": "DAVID", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1256088", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210824", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180", "catalog_number": "400180", "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": [ "Material Separation", "Material Separation" ], "reporter_state_code": "CT", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/29/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20210824", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES.", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "39 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12357895", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210729", "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": "267863149", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE MONOPOLAR CURVED SCISSOR (MCS) TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BE DETERMINED. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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 WAS PROVIDED FOR REVIEW. A LOG REVIEW WAS CONDUCTED, WHICH RESULTED IN THE FOLLOWING FINDINGS: THE LOGS SHOW THE CUSTOMER USED MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT PART# 470179-19 LOT# N13210524-0208 ON (B)(6) 2021 DURING A BENIGN HYSTERECTOMY PROCEDURE ON SYSTEM SK2118. THE INSTRUMENT WAS LAST USED ON (B)(6) 2021 WITH SYSTEM SK2118 AND HAD 9 LIVES REMAINING. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INTO THE PATIENT AND WAS RETRIEVED. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, RECURRENCE OF THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT." }, { "mdr_text_key": "267863150", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE SCISSORS TIP/SLEEVE COVER FELL OFF INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2021. THE CHARGE NURSE REPORTED THEY SHE WAS NOT PRESENT DURING THE REPORTED ISSUE; HOWEVER, WAS CALLED INTO THE ROOM AFTER THE ISSUE OCCURRED AND ASSISTED THE STAFF. THE CHARGE NURSE INFORMED THAT THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE INSTALLATION TOOL WAS USED AND NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE STAFF INFORMED THE CHARGE NURSE THAT DURING THE CASE, THEY HAD OBSERVED THE MCS TIP COVER ACCESSORY STARTING TO SLIDE OFF AND DECIDED TO REMOVE THE INSTRUMENT. HOWEVER, AT THE MOMENT THEY REMOVED THE INSTRUMENT THROUGH THE TROCAR, THE MCS TIP COVER ACCESSORY FELL OFF AND INTO THE PATIENT. IT WAS NOTED THE PROCEDURE HAD BEEN IN PROGRESS FOR ABOUT FIVE HOURS. IT WAS UNKNOWN IF ANY LUBRICANT WAS USED PRIOR TO THE MCS TIP COVER ACCESSORY INSTALLATION. NO REDUCER WAS USED, AND IT WAS UNKNOWN IF ANY INSTRUMENT COLLISION HAD BEEN EXPERIENCED. A LAPAROSCOPIC INSTRUMENT WAS USED TO REMOVE THE MCS TIP COVER ACCESSORY. NO IMAGE/VIDEO WAS AVAILABLE FOR REVIEW. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY OR HARM. ISI FOLLOWED UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR) ON (B)(6) 2021 AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE CSR NOTED THAT SHE WAS NOT PRESENT DURING THE REPORTED CASE; AND THE CUSTOMER PROVIDED THE ANSWERS TO HER. THE CUSTOMER STATED THAT THE REPORTED ISSUE OCCURRED DURING A BENIGN HYSTERECTOMY PROCEDURE. IT WAS NOTED THAT THE CUSTOMER WAS NOT SURE IF THE MCS TIP COVER ACCESSORY WAS INSPECTED, BUT INFORMED THAT IT IS TYPICALLY PERFORMED AT THE INSTITUTION. IT WAS UNKNOWN IF THERE WAS ANY DAMAGE OBSERVED. THE CUSTOMER IS EXPECTED TO RETURN THE MCS TIP COVER ACCESSORY FOR ANALYSIS, IT WAS UNKNOWN IF THE MCS INSTRUMENT WOULD BE RETURNED." }, { "mdr_text_key": "335846046", "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": "335846047", "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" } ] }