MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that on (b)(6) 2026, during use of an affirm prone biopsy system, 3d, the stage arm unlatched during a biopsy procedure following the post-fire image pair.The user site reported that the stage arm began reporting as unlocked and staff were unable to proceed with the procedure as exposures were prevented.It was further reported that the biopsy needle was already inserted in the patient¿s breast when the stage arm lock released.The user site reported that the staff attempted to re-lock the stage arm but the system did not update to a ready status.The user site reported that the biopsy procedure was partially completed as the calcifications were obtained, however verification images for the marker could not be acquired.No patient injuries were reported.A field service engineer (fse) the authorized dealer investigated the system.The fse powered down the system and the stage arm covers were removed.The fse removed and replaced the plunger, motor, and optical sensors associated with the stage arm detent mechanism.The fse routed and reconnected the cables to the control board and the system was powered on.The stage arm detent calibration was performed by the fse and the stage arm was verified to lock securely at all detent positions.The fse completed quality assurance testing and verified that the numbers were exceptional, and the fse reported that the system was up and operating properly.No further information is currently available.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM, 3D
• Common Device Name: BREAST BIOPSY 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: ugo chibueze ; 445 simarano dr; marlborough, MA 01752
• MDR Report Key: 25131264
• Report Number: 3005496266-2026-00098
• Device Sequence Number: 13091742
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: (01)15420045506510(11)210524
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K153486
• 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): 07/30/2026

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: PBX-SYS-AFFIRM-3D
• Device Catalogue Number: PBX-SYS-AFFIRM-3D
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 07/30/2026
• 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