MAUDE Adverse Event Report: Hologic, Inc Affirm Breast Biopsy Guidance System

Model Number	STLC-00004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during a breast biopsy procedure on (b)(6) 2026, the "targeting is off." it is reported that the procedure was successfully completed; however, an additional skin incision to the patient was required after repositioning.A remote case review with the manufacturer technical support was held with the user site.Technical support found that "the patient was pulling back causing multiple retargets." additionally, it was determined that the user site was not "nicking the skin prior to entering the needle.This could be why they are not able to get to all green and may be getting 0.1mm on the diff line for x." technical support further indicates that the user site provided updated information and confirmed that they have completed additional biopsies after the case review was held and since "using a nick in the skin.The radiologist has not had any further issue"[s]" with their biopsies." 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 drive; newark DE 19702
• Manufacturer (Section G): Hologic, Inc; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 50302612
• Report Number: 3005496266-2026-00219
• Device Sequence Number: 18704001
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103512
• 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): 08/18/2026

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: STLC-00004
• Device Catalogue Number: STLC-00004
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/18/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown