MAUDE Adverse Event Report: HOLOGIC, INC ATEC 0912-20; INSTRUMENT, BIOPSY

Model Number	ATEC 0912-20
Medical Device Problem Codes	Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during and atec procedure on (b)(6) 2025, the user observed excessive "grease" around the opening of the tissue collection chamber.It is reported that the user utilized the device and successfully completed the patient procedure; however, observed a foreign particle in the tissue sample.No patient or user injury was reported, and no further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during and atec procedure on (b)(6) 2025, the user observed excessive "grease" around the opening of the tissue collection chamber.It is reported that the user utilized the device and successfully completed the patient procedure; however, observed a foreign particle in the tissue sample.No patient or user injury was reported.The device was returned to the post market quality laboratory for investigation.Visual inspection was conducted, and the inspection revealed the cut block damaged.Functional testing was not conducted.The visual inspection identified the cut block damaged, consistent with the initial evaluation, confirming the failure.The complaint was confirmed, and root cause analysis determined that the failure was attributable to the cut block, which was damaged, as identified during the visual inspection.According to the investigation, the foreign body visible in the tissue sample is probably a piece of cut block, which is biocompatible and most probably does not present any kind of risk or harm to the patient because of its composition.Conclusion: the reported issues have been confirmed, and the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: yes.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no relevant risk factors were found in the manufacturing process.

• Brand Name: ATEC 0912-20
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23328152
• Report Number: 1222780-2025-00543
• Device Sequence Number: 9910455
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: (01)15420045504868(17)270519(10)E25E19RH
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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 0912-20
• Device Catalogue Number: ATEC 0912-20
• Device Lot Number: E25E19RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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