{ "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": 23840 } }, "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": "2020394-2020-03242", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K051158", "date_of_event": "20200422", "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", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "466057", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "ENCOR BIOPSY PROBE", "generic_name": "BIOPSY INSTRUMENT", "manufacturer_d_name": "BARD PERIPHERAL VASCULAR, INC.", "manufacturer_d_address_1": "1625 W 3RD ST.", "manufacturer_d_address_2": "", "manufacturer_d_city": "TEMPE", "manufacturer_d_state": "AZ", "manufacturer_d_zip_code": "85281", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "85281", "device_operator": "HEALTH PROFESSIONAL", "model_number": "ECP017G", "catalog_number": "ECP017G", "lot_number": "VTCY0558", "other_id_number": "", "device_availability": "No", "device_report_product_code": "KNW", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00801741086281", "udi_public": "(01)00801741086281", "openfda": { "device_name": "Instrument, Biopsy", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1075", "device_class": "2", "registration_number": [ "2020394" ], "fei_number": [ "2020394" ] } } ], "product_problems": [ "Suction Problem", "Suction Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20200427", "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": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10001389", "removal_correction_number": "Z-2211-2019", "number_devices_in_event": "", "date_manufacturer_received": "20200422", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189058993", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A CUSTOMER NOTIFICATION WAS ISSUED FOR THE ENCOR BREAST BIOPSY PROBE FOR SPECIFIC PRODUCT CODE/LOT NUMBER COMBINATIONS. THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS MAY BE AT RISK OF EXPERIENCING A LEAK BETWEEN THE PROBE AND THE TISSUE COLLECTION CHAMBER, WHICH COULD RESULT IN MINIMAL SUCTION, LEAKAGE, MINIMAL OR NO TISSUE SAMPLE OBTAINED, OR AN EGRESS OF FLUIDS FROM THE DEVICE. A ROOT CAUSE INVESTIGATION AND FIELD ACTION DETERMINATION WAS CONDUCTED AS A RESULT OF AN INCREASE IN COMPLAINTS FOR LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. THE INVESTIGATION INCLUDED AN EXTENSIVE MANUFACTURING REVIEW, RISK DOCUMENTATION REVIEW FOR THE THREE REPORTED MALFUNCTIONS, AND EVALUATIONS PERFORMED ON THE RETURNED DEVICES. THE INVESTIGATION IDENTIFIED THAT ONE OF THE FEATURES ON THE TRAP CHAMBER WAS UNDER SPECIFIED AND DURING THE IMPLEMENTATION OF A NEW TRAP CHAMBER (B)(4) MOLD, ONE OF THE DIMENSIONS CHANGED AND WENT UNDETECTED, CREATING A DIFFERENCE BETWEEN THE AMOUNT OF SPACE THAT THE SEAL HAS BETWEEN THE TRAP CHAMBER AND THE FRONT SEAL CAP. THIS GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP RESULTED IN CONDITIONS THAT LED TO A HIGHER LIKELIHOOD OF LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. ALL REPORTED COMPLAINTS FROM THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS THAT ARE POSSIBLY RELATED TO THE GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP HAVE BEEN CLASSIFIED AS LEAK, SUCTION ISSUES), OR FAILURE TO OBTAIN SAMPLES. THIS REPORTED COMPLAINT IS FROM AN AFFECTED LOT NUMBER THAT WAS REPORTED FOR ONE OF THESE TRAP CHAMBER ISSUES. (EXPIRY DATE 11/2020), (B)(4)." }, { "mdr_text_key": "189058994", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BREAST BIOPSY THROUGH FIBROADENOMA, THE DEVICE ALLEGEDLY HAD A SUCTION ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY." } ], "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": "" } ] }