{ "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": "2955842-2021-11282", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20211010", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20210820", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20211010", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1500568", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211010", "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": "M90201127", "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": "10886874111045", "udi_public": "(01)10886874111045(10)M90201127", "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 Split, Cut or Torn", "Material Separation", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/14/2021", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20211010", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20210914", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "12602638", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210914", "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": "335535555", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "335535556", "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": "284020796", "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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECT TO THE PATIENT. PER SUBSEQUENT FOLLOW-UP ON 21-SEP-2021, THE INITIAL REPORTER CONFIRMED THAT THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS OBSERVED. IT WAS CONFIRMED THAT THE COVER FELL OFF INSIDE PATIENT AND WAS RETRIEVED BY LAPAROSCOPIC YOHAN FORCEPS VIA THE ASSISTANT PORT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS DURING THE SURGICAL PROCEDURE. NOTHING ABNORMAL TOOK PLACE. THE MCS INSTRUMENT WRIST WAS STRAIGHTENED, AND NO RESISTANCE WAS FELT UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. AFTER THE EVENT OCCURRED, THE SURGICAL STAFF NOTICE THAT THE MCS TIP COVER ACCESSORY HAD A SMALL SPLIT AT THE SCISSOR BLADE END. THE INITIAL REPORTER CONFIRMED THE FOLLOWING: THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE; NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE INSTALLATION TOOL WAS USED AS PER TRAINING, AND ELECTROLUBE/OTHER LUBRICANT WAS NOT APPLIED TO THE MCS INSTRUMENT PRIOR TO MCS TIP COVER ACCESSORY INSTALLATION. THE PROCEDURE WAS NOT SIGNIFICANTLY PROLONGED AS A RESULT OF THE ISSUE. THE MCS TIP COVER ACCESSORY WAS NOT RETAINED AS IT WAS CONTAMINATED WITH BLOOD AND BODY FLUIDS. THEREFORE THE PRODUCT WILL NOT BE RETURNED TO ISI FOR EVALUATION. PATIENT-RELATED INFORMATION WAS REQUESTED BUT WERE UNABLE TO BE PROVIDED." }, { "mdr_text_key": "284020797", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAS BEEN SCRAPPED AND IS NOT AVAILABLE FOR INVESTIGATION PURPOSES. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE WAS UNABLE TO BE DETERMINED FOR THIS ALLEGED ISSUE SINCE THE INSTRUMENT COULD NOT BE EVALUATED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THE CUSTOMER PROVIDED AN IMAGE OF AN MCS TIP COVER ACCESSORY AND OUTLINED LOCATION OF THE SPLIT ON IMAGE. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE MCS TIP COVER ACCESSORY REPORTEDLY FELL OFF OF THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT. THE ITEM WAS RETRIEVED DURING THE SAME PROCEDURE AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. ALTHOUGH THERE WAS NO PATIENT INJURY THAT RESULTED FROM THIS EVENT, IF THE ISSUE WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. THE MANUFACTURE DATE WAS NOT AVAILABLE." } ], "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" } ] }