MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow-up report will follow with the information from the dhr.
Event or Problem Description
It was reported that during an atec sapphire breast biopsy procedure on (b)(6) 2026, the user observed "the cord attached to the footswitch on the side of the device, the plastic coating cracked near the vacuum and has exposed "wires." it was further reported that the patient procedure was not completed.Several attempts to obtain additional information from the user were unsuccessful.No patient harm was reported, and no additional information is currently available.

• Brand Name: ATEC SAPPHIRE
• 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: 24831673
• Report Number: 1222780-2026-00161
• Device Sequence Number: 18749459
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: 15420045504295
• 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): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ATEC SAPPHIRE
• Device Catalogue Number: ATEC SAPPHIRE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown