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

Model Number	ATEC 0912-20
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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
The customer reported on (b)(6) 2025, that there was the presence of grease on the atec needle, specifically at the distal end near the collection chamber.The customer observed that, on certain occasions, the amount of grease appears excessive, and expressed concern that this may inhibit the proper deployment of the marker.Further investigation found that the marker was successfully deployed in all affected cases.It was further reported that in addition to excessive grease, foreign material was observed when imaging the biopsy sample.It is reported that the foreign material is sometimes covering the micro calcifications.No patient injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: the customer reported on october 8th, 2025, that there was the presence of grease on the atec needle, specifically at the distal end near the collection chamber.The customer observed that, on certain occasions, the amount of grease appears excessive, and expressed concern that this may inhibit the proper deployment of the marker.Further investigation found that the marker was successfully deployed in all affected cases.It was further reported that in addition to excessive grease, foreign material was observed when imaging the biopsy sample.It is reported that the foreign material is sometimes covering the micro calcifications.No patient injury was reported.The device was not returned for this complaint.Therefore, a full investigation could not be conducted.Without the returned sample, it is not possible to confirm a definitive root cause of the issue.It was not possible to confirm that the atec disposable directly caused the reported issue.However, based on the severity of the reported issue the investigation determined that the most probable cause of the device issue was an excessive amount of grease.The excessive grease in the filter canister is present during manufacturing and is typically found in the filter tissue area.This situation is currently not considered a critical step to be performed by an automated process, and the observed grease is biocompatible and most probably do not present any kind of risk or harm to the patient because of its composition.Although this is not deemed a critical step in the current process, a new container for grease application on the tissue filter component of the atec product was implemented to help prevent this type of issue in the future.Conclusion: the reported issue could not be confirmed because the device was not returned, however, the most probable root cause has been identified.A comprehensive review was conducted, including device history records, complaint data, and risk assessments.The root cause was previously addressed through an engineering change order (eco).This eco covered the failure mode reported and implemented corrective actions.The investigation suggests this is not a recurring issue within the product family, system, or failure mode referenced in the complaint.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Complaint confirmed: no.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: 23583753
• Report Number: 1222780-2025-00592
• Device Sequence Number: 9533211
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: (01)15420045504868(17)261009(10)E24K09RN
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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: E24K09RN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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