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	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a atec breast biopsy procedure on (b)(6) 2026, the user experienced issues with the device suction "when approximately one-third of the nodule remained." it is reported that the disposable needle was replaced; however, the user reports the procedure still could not be continued.It is reported that no error messages were observed and a request for service was submitted.The user site further reports that upon the arrival of the engineer, the system passed the self-testing; however, "the suction generated was still insufficient to support completion of the excision by the breast surgeon." due to the reported issue experienced by the user, and the inability to complete the procedure utilizing the atec device, the surgical plan was changed to an open procedure.It is reported that the hospital contacted hologic immediately.Hologic then notified the distributor to provide a backup unit as soon as possible, and a field service engineer was arranged to perform an on-site inspection and repair, including replacement of the probe and inspection of the tubing.Subsequently, a hologic field engineer provided on-site support during the procedure, and the device functioned normally.Additional information was obtained from a regional hologic sales manager, in which it was reported that "after reviewing the complaint and on-site actions, we have determined that the root cause of the customer¿s issue was related to the disposable needle and not the atec sapphire console.The system¿s successful self-test when the engineer arrived further supports this conclusion.The backup atec sapphire console was provided to the customer out of an abundance of caution, as the customer expressed reduced confidence in the original unit following the event.This was a proactive step to restore clinical operations, and not an indication of a confirmed console malfunction.Since the incident, the hospital has continued to use both atec sapphire consoles (including the backup unit provided) and our consumables without any further adverse events or performance issues.This ongoing stable usage further confirms that the issue was isolated to the specific disposable needle involved." no further information is currently available.

• 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: 25349192
• Report Number: 1222780-2026-00341
• Device Sequence Number: 10445066
• Product Code: KNW
• UDI-Device Identifier: 15420045504868
• UDI-Public: (01)15420045504868(17)270728(10)E25G28RK
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/01/2026

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 Model Number: ATEC 0912-20
• Device Catalogue Number: ATEC 0912-20
• Device Lot Number: E25G28RK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown