{ "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": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 413 } }, "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": "Malfunction", "report_number": "9611894-2020-00001", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "K080871", "date_of_event": "20200331", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "OTHER", "USER FACILITY" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "TH", "manufacturer_contact_area_code": "", "date_added": "20200429", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "476208", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200429", "brand_name": "TROCAR POINT TITANIUM NEEDLE SETS", "generic_name": "SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED", "manufacturer_d_name": "NUCLETRON B.V.", "manufacturer_d_address_1": "WAARDGELDER 1", "manufacturer_d_address_2": "", "manufacturer_d_city": "VEENENDAAL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "3905", "manufacturer_d_zip_code_ext": "TH", "manufacturer_d_country": "NL", "manufacturer_d_postal_code": "3905 TH", "device_operator": "HEALTH PROFESSIONAL", "model_number": "189989P01-00", "catalog_number": "", "lot_number": "1000064515", "other_id_number": "", "device_availability": "Yes", "device_report_product_code": "JAQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08717213020788", "udi_public": "08717213020788", "openfda": { "registration_number": [ "9611894" ], "fei_number": [ "3002807741" ], "device_name": "System, Applicator, Radionuclide, Remote-Controlled", "medical_specialty_description": "Radiology", "regulation_number": "892.5700", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", null, "Break", "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/31/2020;03/31/2020", "mfr_report_type": "", "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": "20200429", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Device Embedded In Tissue or Plaque", "Foreign Body In Patient", "Device Embedded In Tissue or Plaque" ] } ], "distributor_city": "", "date_report": "20200729", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10008721", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200331", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Replace" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "217372479", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED." }, { "mdr_text_key": "217372480", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE CUSTOMER REPORTED THAT THE TIP OF THE TROCAR NEEDLE BROKE AND WAS STUCK INSIDE THE PATIENT. SURGICAL CAMERA WAS USED TO ASSIST THE REMOVAL OF THE TIP OF THE NEEDLE. THE PATIENT WAS DISCHARGED WITH AN ANTIBIOTIC MEDICINE." }, { "mdr_text_key": "318849233", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "G1-2 CONTACT OFFICE: ADDRESS UPDATED. H6 ADDED CODING. H7 ADDED INFORMATION. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE RETURNED NEEDLES WERE EXAMINED AND IT WAS FOUND THAT THE NEEDLES WERE BADLY DEFORMED AND SHOWED SIGNS OF REPEATED BENDING AND STRAIGHTENING. THE NEEDLE WITH THE BROKEN TIP HAD MULTIPLE BENDS. THERE WERE NO SIGNS OF MECHANICAL DEFORMATION OR WEAR AND THERE WAS NO VISIBLE SOLDER OR HEAT PRINT/DISCOLOURATION PRESENT. THE TIPS OF THE OTHER RETURNED NEEDLES WERE ALL FIXATED PROPERLY AND ALSO SHOWED NO SOLDER OR HEATPRINT AT THE TRANSITION. THERE IS NO INDICATION OF A MANUFACTURING ISSUE. THE NEEDLES WERE IN USE SINCE AUGUST 2016 AND ARE PAST ITS LIFE EXPECTANCY. THE INFORMATION PROVIDED IN THE 'INSTRUCTIONS FOR USE' STATES THAT THE PACKAGING AND SHELF LIFE OF THE PRODUCT SHOULD BE REGULARLY INSPECTED AND IF NEEDLES BECOME DEFORMED THEY SHOULD BE REMOVED FROM CLINICAL USE. THE NEEDLES HAVE BEEN REPLACED." }, { "mdr_text_key": "319701376", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SECTION G7: REPORT WAS SUBMITTED AS FOLLOW-UP 2 DUE TO AN ERROR IDENTIFIED IN FOLLOW-UP 1. SECTION E1 REPORTER NAME AND ADDRESS: UNITED STATES WAS SELECTED IN FOLLOW-UP 1 REPORT BUT SHOULD HAVE BEEN THAILAND. IT HAS BEEN CORRECTED IN THIS FOLLOW-UP REPORT. SECTION H2: CORRECTION TICKED." } ], "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": "07/29/2020;07/29/2020" } ] }