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

Model Number	ATEC 0912-20
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
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 an atec procedure on (b)(6) 2025, "the setup, test and lavage mode passed, but although the aperture was opening and closing, no tissue was being collected." additionally, it was reported that, "these new needles are delivered with an excessive amount of grease on the handpiece area, particularly around the basket-to-handpiece connection.This does affect the suction performance, especially with larger lesions or when a complete excision is intended." it is reported that the patient procedure was aborted.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an atec procedure on (b)(6) 2025, "the setup, test and lavage mode passed, but although the aperture was opening and closing, no tissue was being collected." additionally, it was reported that, "these new needles are delivered with an excessive amount of grease on the handpiece area, particularly around the basket-to-handpiece connection.This does affect the suction performance, especially with larger lesions or when a complete excision is intended." it is reported that the patient procedure was aborted.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event.The device was not returned for this complaint, and only limited patient-related information was provided.Based on the available information, the dealer reported "additionally, these new needles are delivered with an excessive amount of grease on the handpiece area, particularly around the basket-to-handpiece connection.This does affect the suction performance, especially with larger lesions or when a complete excision is intended", which was considered relevant to the failure mode.Investigation of this issue was conducted through customer-provided information, historical complaint review, analysis of similar events, and evaluation of product design.The investigation determined that the most probable cause of the device issue was an excessive amount of grease, as identified during the visual inspection.The excessive grease in the filter canister/tissue chamber 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.The grease is manually applied and although this is not deemed a critical step in the current process, an engineering change order implemented a new container for grease application on the tissue filter component of the atec product to help prevent this type of issue in the future.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.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: 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: 23770489
• Report Number: 1222780-2025-00628
• Device Sequence Number: 9743271
• Product Code: KNW
• UDI-Device Identifier: 15420045504851
• UDI-Public: (01)15420045504851(17)260801(10)E24H01R
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: ATEC 0912-20
• Device Catalogue Number: ATEC 0912-20
• Device Lot Number: E24H01R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown