MAUDE Adverse Event Report: Hologic, Inc. ATEC 1212-20; INSTRUMENT, BIOPSY

Model Number	ATEC 1212-20
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during a mammotomy procedure, "the biopsy needle had to be replaced because it lost vacuum during the procedure." as a result of the reported malfunction, tissue could not be adequately acquired from the target area with the initial device.No patient or user harm was reported.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report as no lot / serial number information was reported.A follow-up report will be submitted in the event additional information is received.

• Brand Name: ATEC 1212-20
• 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: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50839941
• Report Number: 1222780-2026-00608
• Device Sequence Number: 21344984
• Product Code: KNW
• UDI-Device Identifier: 15420045504912
• UDI-Public: 15420045504912
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative,Distributor
• 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 1212-20
• Device Catalogue Number: ATEC 1212-20
• Device Lot Number: Not reported
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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