MAUDE Adverse Event Report: HOLOGIC, INC. AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Model Number	STLC-00004
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that during an affirm breast biopsy guidance system procedure on (b)(6) 2026, that the customer experienced a targeting issue in which the targeted area appeared to be misaligned with the needle position.It was reported by the user site that procedure was not completed, and the patient was rescheduled to return for the biopsy.No user or patient injuries were reported.An applications specialist conducted a remote case review with the technologist and noted that the breast thickness was 26 mm while a standard needle was used; a standard needle is recommended for breast thicknesses of 28 mm or greater, and a petite needle is recommended for a 26 mm breast thickness.During the review, pending targets could not be placed on the stereo image pair to determine the x, y, and z coordinates because one of the stereo images included part of the patient's head and was therefore not usable.The physician elected not to continue the procedure and rescheduled the patient to return for the biopsy, requesting that the system be checked by service prior to the patient¿s return.A hologic field service engineer (fse) was dispatched to investigate the device and performed system integrity checks, qas targeting verification, image quality verification, and snr uniformity testing.The system passed all tests and calibrations and was verified to be operating within manufacturer specifications.No further information is currently available.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Common Device Name: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 600 technology dr; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC.; 600 technology dr; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology dr; newark, DE 19702
• MDR Report Key: 24646225
• Report Number: 3005496266-2026-00056
• Device Sequence Number: 18588440
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: (01)15420045505858(11)200221
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K122836
• 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,Followup
• Report Date (Section B): 07/31/2026

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: STLC-00004
• Device Catalogue Number: STLC-00004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 07/31/2026
• 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