{ "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": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2021-10357", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20210405", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210311", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20210405", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "513037", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210405", "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": "400180-14", "catalog_number": "400180", "lot_number": "M90190820", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210325", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)M90190820", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Energy Output Problem", "Energy Output Problem" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "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": "20210405", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Vascular Problem", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Vascular Problem" ] } ], "distributor_city": "", "date_report": "20210311", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11612355", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210311", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "261204869", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY (PN: 400180-14// LN: M90190820 ) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) CONCLUDED THAT THE REPORTED FAILURE WAS NOT CONFIRMED NOR REPLICATED. THE ACCESSORY WAS VISUALLY INSPECTED AND NO DAMAGE WAS FOUND. THE REPORTED SYMPTOM WAS NOT FOUND RELATED TO THE REPORTED ACCESSORY. IT IS LIKELY THE WRONG PART WAS RETURNED WITH THIS COMPLAINT. THE ROOT CAUSE CANNOT BE TRACED TO THIS DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON (B)(6) 2021 FOR A PROCEDURE ON (B)(6) 2021 ON SYSTEM (B)(4). 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. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. A MONOPOLAR CURVED SCISSORS (MCS) PN: 420179-22 // LN: N10200406-905 // SN: (B)(4) WAS RECORDED IN USE AND IT HAD 7 OF 10 USES REMAINING. WHILE NOT ALL OTHER REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE COMPLAINT HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AN ISI CLINICAL DEVELOPMENT ENGINEER (CDE) CONDUCTED PHOTOGRAPH REVIEW OF THE DAMAGED MCS TIP COVER ACCESSORY AND FOUND THE FOLLOWING: THE PICTURE SHOWS A TEAR IN THE MOUTH PORTION (I.E. THE CLEAR PART) OF THE MCS TIP COVER, CLOSEST TO THE BLADES WHICH SHOULD BE UNDER CONSTANT OBSERVATION. IN ADDITION, WHILE THE TIP COVER IS A SINGLE-USE ACCESSORY, MECHANICAL WEAR CAN JUST HAPPEN AT THE MOUTH, AND IT SHOULD BE PERIODICALLY INSPECTED DURING USE AND REPLACED IF CRACKS ARE OBSERVED. THE BLOOD IN THE IMAGE MAKES IT DIFFICULT TO SEE, BUT WITH AN ARCING ALLEGATION, WE WOULD EXPECT TO SEE MELTING OR BLACKENING OF THE TIP COVER. AN ISI ADVANCED FAILURE ANALYST (AFA) CONDUCTED PHOTOGRAPH REVIEW OF THE DAMAGED MCS TIP COVER ACCESSORY AND FOUND THE FOLLOWING: THIS TYPE OF DAMAGE IS TYPICALLY CAUSED BY REPEATED MECHANICAL/THERMAL STRESSES TO THE INSTRUMENT TIP COVER ACCESSORY . WE SEE THERE IS AN INJURY DUE TO AN INSULATION FAILURE FOR THIS CASE AND THEY HAD NOT NOTICED THE TEAR UNTIL THE BLEED WAS IDENTIFIED. THE TEAR APPEARS TO HAVE EXTENDED INTO THE GREY PORTION OF THE TIP COVER ACCESSORY. WHILE THERE WAS NO CONFIRMED VISIBLE ARCING INTRA-OPERATIVELY, IT WAS ALLEGED THAT THERE WAS INTRA-OPERATIVE ARCING FROM A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT RESULTING IN AN UNSPECIFIED AMOUNT OF BLEEDING FROM AN UNDISCLOSED ARTERY. AN UNSPECIFIED AMOUNT OF BLOOD WAS TRANSFUSED AND THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE CONVERTED TO OPEN RADICAL NEPHRECTOMY SURGERY. THIS EVENT IS CONSIDERED REPORTABLE AS THE MCS TIP COVER ACCESSORY WAS DAMAGED DUE TO ALLEGED ARCING FROM AN UNSPECIFIED LOCATION ON THE TIP COVER. ADDITIONALLY, THERE WAS AN UNSPECIFIED AMOUNT OF BLEEDING THAT REQUIRED A BLOOD TRANSFUSION AND THE PROCEDURE CONVERTED TO OPEN SURGERY. AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND THE INTRA-OPERATIVE COMPLICATION IS UNKNOWN." }, { "mdr_text_key": "261204870", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, A TIP COVER ¿SPLIT¿ ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHICH RESULTED IN AN, ¿INVERTED BLEED FROM AN ARTERY¿. TO RESOLVE THE ISSUE, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY TO CONTROL THE BLEEDING. THE PATIENT WAS REPORTED AS BEING IN STABLE CONDITION FOLLOWING THE PROCEDURE. ON 15-MAR-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: DURING A DA VINCI-ASSISTED PARTIAL RETROPERITONEAL NEPHRECTOMY PROCEDURE, AN ¿MCS TIP COVER WAS TORN AT SOME POINT DURING THE PROCEDURE AND NOBODY NOTICED IT¿. THE SITE BELIEVED THAT THERE WAS ARCING THAT CAUSED, ¿EXCESSIVE BLEEDING TO AN UNSPECIFIED ARTERY WHICH REQUIRED A BLOOD TRANSFUSION¿, UNKNOWN AMOUNT, AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHERE THE BLEEDING WAS COMING FROM AND DID NOT KNOW WHAT CAUSED THE BLEEDING. THE DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE CONVERTED TO OPEN RADICAL NEPHRECTOMY SURGERY. THE OPEN PROCEDURE COMPLETED. THE PATIENT WAS DESCRIBED AS DOING WELL POST-OPERATIVELY. INTUITIVE SURGICAL, INC. (ISI) HAS REACHED OUT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }