MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM FOR SELENIA DIMENSIONS

Model Number	RM-STLC-00004
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that on (b)(6) 2026, during a biopsy procedure using the affirm breast biopsy guidance system, a needle struck the detector, resulting in a dent in the detector cover.The site reported that an incorrect needle type had been selected prior to deployment.When the needle was fired, it contacted the detector platform, and the patient sustained a small nick at the bottom of the breast.It was reported that the needle passed through the patient¿s breast.No additional medication or medical treatment was required, and the procedure was completed using the same needle.A hologic field service engineer (fse) inspected the device and confirmed that there was no damage to the detector.The fse replaced the breast platform and performed system gain calibration and artifact evaluation.The new breast platform was verified by the fse to have no issues.No further information is currently available.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM FOR SELENIA DIMENSIONS
• 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: 25326241
• Report Number: 3005496266-2026-00124
• Device Sequence Number: 18593394
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/26/2026

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: RM-STLC-00004
• Device Catalogue Number: RM-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: 04/28/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2020
• 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