{ "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": 3228 } }, "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": "9616793-2020-00087", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200429", "manufacturer_address_2": "", "pma_pmn_number": "K121251", "date_of_event": "20200330", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "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": "472110", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200429", "brand_name": "ICEROD CX 90 NEEDLE/VL", "generic_name": "CRYOABLATION NEEDLE", "manufacturer_d_name": "GALIL MEDICAL LTD.", "manufacturer_d_address_1": "1 TAVOR BUILDING", "manufacturer_d_address_2": "P.O. BOX 224, INDUSTRIAL PARK", "manufacturer_d_city": "YOKNEAM,", "manufacturer_d_state": "", "manufacturer_d_zip_code": "20692", "manufacturer_d_zip_code_ext": "03", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "2069203", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20211117", "model_number": "FPRPR3533", "catalog_number": "FPRPR3533", "lot_number": "T0467", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GEH", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290104830587", "udi_public": "07290104830587", "openfda": { "registration_number": [ "9616793" ], "fei_number": [ "3002843919" ], "device_name": "Unit, Cryosurgical, Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4350", "device_class": "2" } } ], "product_problems": [ "Appropriate Device Problem Term/Code Not Available", "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/27/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200904", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10008639", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200330", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "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": "315704357", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE NEEDLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE REPORTED COMPLAINT AND ITS ASSOCIATED ROOT CAUSE COULD NOT BE CONFIRMED. REVIEW OF THE NEEDLE LOT MANUFACTURING RECORDS DID NOT IDENTIFY ANY VACUUM SLEEVE MALFUNCTIONS WITHIN THE NEEDLE BATCH." }, { "mdr_text_key": "315704358", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS MDR IS TO DOCUMENT THE MANUFACTURER'S INVESTIGATION OF THE NEEDLE USED IN THE REPORTED EVENT. FURTHER INVESTIGATION OR FOLLOW-UP IS NOT PLANNED FOR THIS COMPLAINT." }, { "mdr_text_key": "189305276", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE USER REPORTED FROST FORMATION ON THE NEEDLE SHAFT ON ONE OF THE NEEDLES USED DURING A CRYOABLATION PROCEDURE. FOUR NEEDLES WERE USED IN THIS CASE. FROST FORMED ON THE NEEDLE SHAFT UP TOWARDS THE HANDLE. THE CASE WAS COMPLETED WITH NO REPORTED PATIENT INJURY. THE NEEDLE WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION." } ], "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": "09/04/2020" } ] }