{ "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": "2955842-2021-10637", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20210611", "manufacturer_address_2": "", "pma_pmn_number": "K133845", "date_of_event": "20210514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20210611", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "882708", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20210611", "brand_name": "DA VINCI", "generic_name": "CANNULA SEAL", "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", "expiration_date_of_device": "20210517", "model_number": "470361-08", "catalog_number": "470361", "lot_number": "L13210113", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210624", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "10886874112547", "udi_public": "(01)10886874112547(10)L13210113", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "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": "06/11/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250806", "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": "20210611", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210517", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "11987078", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210517", "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": "325476002", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FOLLOW UP ACTIVITY CONDUCTED ON 11-JUN -2021 OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AN INSPECTION OF THE SYSTEM, INSTRUMENTS AND ACCESSORIES WAS PERFORMED PRIOR TO USE AND NO ISSUES WERE FOUND. THE ISSUE OCCURRED RIGHT AROUND THE TIME WHEN THE INSTRUMENT WAS INSTALLED ON THE SYSTEM. NO POST-OPERATIVE TESTS (I.E. X-RAY OR ULTRA SOUND) WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS AND THE SURGEON STATED THAT NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE CANNULA SEAL IDENTIFIES DAMAGE CONSISTENT WITH THE CUSTOMER REPORTED ALLEGATION. D11 - ISI RECEIVED THE CANNULA SEAL INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. INSPECTION FOUND THAT THE CANNULA SEAL WAS BROKEN AT THE SEPTUM. A BROKEN PIECE MEASURING APPROXIMATELY 0.053\" X 0.078\" WAS RETURNED. THE KNOWN CAUSE OF THIS ISSUE IS ATTRIBUTED TO MISHANDLING AND MISUSE." }, { "mdr_text_key": "325476003", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "256688212", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE CANNULA SEAL FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SYSTEM LOGS USING THE DOCUMENTED SITE NAME HAS BEEN PERFORMED. PER LOGS, A PROCEDURE MATCHING THE REPORTED EVENT DATE OF (B)(6) 2021 USING SYSTEM SK0847 WAS CONFIRMED. DURING THE PROCEDURE, USAGE OF THE MARYLAND BIPOLAR FORCEPS, PROGRASP FORCEPS, MONOPOLAR CURVED SCISSORS, LARGE NEEDLE DRIVER AND MEGA SUTURE CUT NEEDLE DRIVER INSTRUMENTS LOGGED DURING THE PROCEDURE. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS COULD NOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGES OR PROCEDURE VIDEO WERE PROVIDED OR REVIEW. THE CANNULAE, OBTURATORS, SEALS, AND RELATED ACCESSORIES HAVE APPLICATIONS IN ENDOSCOPIC SURGERY TO ESTABLISH A PORT OF ENTRY FOR INTUITIVE SURGICAL DA VINCI ENDOWRIST AND SINGLE-SITE INSTRUMENTS, ENDOSCOPES, OR COMPATIBLE ACCESSORIES. THEY ARE INTENDED TO BE USED ONLY IN A MEDICAL FACILITY, BY TRAINED MEDICAL PROFESSIONALS, IN ACCORDANCE WITH THE USER MANUAL FOR THE DA VINCI SYSTEM. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS CONSIDERED A REPORTABLE ADVERSE EVENT AND MALFUNCTION. THE COMPLAINT ACKNOWLEDGES THAT DEBRIS WAS FOUND INSIDE THE PATIENT; HOWEVER, AT THIS TIME, IT IS UNCLEAR IF THE ORIGIN OF THE FALLEN FRAGMENT CAME FROM THE DAMAGE IDENTIFIED ON THE CANNULA SEAL. IT IS ALSO UNKNOWN WHETHER ALL DEBRIS WAS REMOVED, OR IF THERE MAY HAVE BEEN DEBRIS RETAINED INSIDE THE PATENT. IN ADDITION, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE IS UNKNOWN." }, { "mdr_text_key": "256688213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGICAL PROCEDURE, BLUE DEBRIS WAS FOUND IN THE ABDOMINAL CAVITY. THE SURGEON RECOVERED THE DEBRIS THAT WAS SEEN; HOWEVER, WAS UNABLE TO CONFIRM IF ANY OTHER DEBRIS MAY HAVE BEEN RETAINED INSIDE THE PATIENT. INSPECTION IDENTIFIED PHYSICAL DAMAGE ON THE RUBBER PART OF THE CANNULA SEAL. THE COMPROMISED CANNULA SEAL WAS REPLACED WITH ANOTHER. FOLLOWING THIS, THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED ADDITIONAL INFORMATION RELATED TO THIS EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN RECEIVED." } ], "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": "07/07/2021" } ] }