MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM; SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Codes	Unintended System Motion (1430); Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, during an affirm prone biopsy procedure, the stage arm and needle began to move freely while the needle was inside the patient's breast.A field engineer examined the equipment but was unable to replicate the issue.The field engineer performed system calibrations and confirmed that the system is functioning according to manufacturer specifications.The patient procedure was aborted.
Additional Manufacturer Narrative
On (b)(6) 2025, an incident was reported during a biopsy procedure while using the affirm prone biopsy system.Customer reported that, while performing a biopsy procedure on a patient and moving the c-arm to -15 degree to take the first stereo image, it was observed that the stage arm and the needle positioned inside of the breast were moving in a horizontal plane.Customer reported that error messages were displayed on the system.The biopsy procedure was aborted, and the patient was rescheduled.To troubleshoot, the customer then cleared the error and performed a successful test exposure without the patient.On march 20th, 2025, our hologic field engineer went on site to examine the system.It was confirmed that the stage arm was not properly locked after error messages were displayed on the system resulting in an unintended movement of the stage arm allowing the needle to move in the breast.The field service engineer performed the system hardware calibrations.Customer confirmed that the unintended movement of the needle caused tissue damage to the patient¿s breast.The system was not returned from the field; however, system logs were reviewed.Root cause is unknown, but probable cause is while performing the tube head alignment following the error the operator perceived the shakiness of the alignment motion in a way that they thought the stage arm was also moving as well.In conclusion, there is no indication in the system log files that the stage arm was unlocked or pushed out of detent during an exposure or as the result of the operator bumping the system.Root cause cannot be determined but the probable cause is that the operator perceived stage arm motion during the operator-initiated tube arm motor alignment.The system then correctly gave an error message that the stage arm should not be moved while the biopsy device is in place.The stage arm showed no indication of movement in the log files until the customer requested the stage arm be unlocked.No update to the risk file is required and the risk remains acceptable.This complaint cannot be confirmed.A capa is not required, and future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4).Dhr was reviewed, and no discrepancies were noted.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM
• Common Device Name: SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 21852193
• Report Number: 1220984-2025-00046
• Device Sequence Number: 18168192
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: (01)15420045506510(11)230804
• Combination Product (Y/N): N
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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?: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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