MAUDE Adverse Event Report: Hologic, Inc. ATEC 1212-20; INSTRUMENT, BIOPSY

Model Number	ATEC 1212-20
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that the device "malfunctioned during the breast biopsy procedure." no additional information regarding the nature of the malfunction, patient or user impact, or procedure outcome was provided.Multiple outreach attempts were made to the appropriate regional contact; however, no additional information was obtained.If additional information is later received, the reportability decision will be reevaluated.This report was forwarded by the brazilian competent authority (anvisa) under reference number 2026.08.004729.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.Investigation is ongoing.

• Brand Name: ATEC 1212-20
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): Hologic, Inc.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): Hologic, Inc.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50882354
• Report Number: 1222780-2026-00644
• Device Sequence Number: 10708310
• Product Code: KNW
• UDI-Device Identifier: 15420045504912
• UDI-Public: (01)15420045504912(17)280108(10)E26A08RB
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC 1212-20
• Device Catalogue Number: ATEC 1212-20
• Device Lot Number: E26A08RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown