MAUDE Adverse Event Report: Hologic, Inc. ATEC 0914-20MR; INSTRUMENT, BIOPSY

Model Number	ATEC 0914-20MR
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that, "there was no suction at the time of "[the]" biopsy."[we]" had to dispose the needle and use a new one." additional information was obtained from the user site in which it was confirmed that "a new needle package was opened and used." the user further reported that "there was a new needle insertion at the site of the biopsy." no patient/user harm was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.

• Brand Name: ATEC 0914-20MR
• 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 dr; newark, DE 19702
• MDR Report Key: 50841356
• Report Number: 1222780-2026-00612
• Device Sequence Number: 10263299
• Product Code: KNW
• UDI-Device Identifier: 15420045504899
• UDI-Public: (01)15420045504899(17)280706(10)E26G07RF
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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 0914-20MR
• Device Catalogue Number: ATEC 0914-20MR
• Device Lot Number: E26G07RF
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown