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

Model Number	STLC-00004
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, during a breast biopsy procedure using the affirm breast biopsy guidance system with an eviva 0913-20 needle, unintended movement of the z-axis occurred when the needle was fired.The radiologist reported that the needle was already inside the patient¿s breast in the pre-fire position, and after firing, the needle rose upwards on its own due to this z-axis movement.Upon noticing the unexpected movement, the radiologist considered the targeting unreliable and stopped the procedure.The biopsy was not completed during this procedure and is scheduled to be repeated on another day.As the patient has been rescheduled, an additional puncture will be required.Apart from this, no medical or surgical intervention has been reported as a result of the unintended movement.The hologic technical service team visited the hospital and checked the system.Following this visit, the field service engineer adjusted the system, and the system is now expected to be working correctly.Subsequently, our clinical application specialist visited the site at the radiologist¿s request.A series of test firings were performed using a chicken phantom, including multiple firings, retargeting and sample collection.During these tests, the z-axis remained stable with no movement or errors observed.A follow-up visit is planned during scheduled patient biopsies to further observe system performance and confirm that the issue does not recur.
Additional Manufacturer Narrative
An investigation was conducted: on (b)(6) 2026, during a breast biopsy procedure using the affirm breast biopsy guidance system with an eviva needle, unintended movement of the z-axis occurred when the needle was fired.The radiologist reported that the needle was already inside the patient¿s breast in the pre-fire position, and after firing, the needle rose upwards on its own due to this z-axis movement.Upon noticing the unexpected movement, the radiologist considered the targeting unreliable and stopped the procedure.The biopsy was not completed during this procedure and is scheduled to be repeated on another day.As the patient has been rescheduled, an additional puncture will be required.Apart from this, no medical or surgical intervention has been reported as a result of the unintended movement.No part or logs were returned/provided so investigation will be limited to a complaint review and risk assessment.The documentation in the complaint indicates the service did some ¿corrections¿ to the system but did not describe in detail what troubleshooting was performed.Following the ¿corrections¿ biopsies were completed with no issue reported from the customer.It is unclear if the service team confirmed the experienced behavior prior to troubleshooting the system.Based on the limited information the root cause is unknown.The probable cause is a failure within the z-axis gear box, potentially the drag brake which aids in holding the needle guide in place against extraneous forces.It is also probable that this can be attributed to use error as the z-axis is manually moved vs the motorized motion of the x and y-axes.Conclusion: in conclusion this complaint cannot be confirmed.Based on the limited information provided the root cause is unknown.The probable cause is a failure within the z-axis gear box, potentially the drag brake which aids in holding the needle guide in place against extraneous forces.It is also probable that this can be attributed to user error as the z-axis is manually moved vs the motorized motion of the x and y-axes.A capa is not needed at this time as there is no evidence of non-conforming product or missing mitigation related to this complaint.Additionally, the risk is considered low based on the occurrence.Future events will be monitored and trended.Device history record (dhr) review: udi: (b)(4).Review of the complaint history showed that during the follow up visit by the fse, no issues were experienced during the biopsies.The dhr was reviewed and no discrepancies were noted.

• 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: ugo chibueze ; 445 simarano dr; marlborough, MA 01752
• MDR Report Key: 24695164
• Report Number: 3005496266-2026-00063
• Device Sequence Number: 21359513
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: (01)15420045505858(11)210212
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/25/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown