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

Model Number	ATEC 0914-20MR
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that the lot was "deemed contaminated with black specks on spike that is inserted into patient's saline." the issue was identified prior to patient use and the device was removed from service.No patient or user harm was reported, and no additional medical or surgical intervention was required.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.Investigation is on going.

• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50842332
• Report Number: 1222780-2026-00614
• Device Sequence Number: 15941989
• Product Code: KNW
• UDI-Device Identifier: 15420045504899
• UDI-Public: (01)15420045504899(17)280713(10)E26G14R
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC 0914-20MR
• Device Catalogue Number: ATEC 0914-20MR
• Device Lot Number: E26G14R
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2026
• 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
• Patient Sex: Unknown