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

Model Number	STLC-00004
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an affirm breast biopsy guidance system procedure on (b)(6) 2025, the user experienced issues obtaining calcifications.It is reported that the user verified the target but could not get proper calcifications.It is reported that the procedure could not be completed, and the patient will be required to return for a repeat biopsy.A hologic field service engineer (fse) was dispatched to examine the device and found that the system is inconsistently losing 0.2-0.3/lbs of force over a period of five minutes.The fse performed several system calibrations to resolve the issue, confirmed that the system passed qas and is operating as expected.The fse reports that the system meets manufacturer specifications.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an affirm breast biopsy guidance system procedure on (b)(6) 2025, the user experienced issues obtaining calcifications.It is reported that the user verified the target but could not get proper calcifications.It is reported that the procedure could not be completed, and the patient will be required to return for a repeat biopsy.A hologic field service engineer (fse) was dispatched to examine the device and found that the system is inconsistently losing 0.2-0.3/lbs of force over a period of five minutes.The fse performed several system calibrations to resolve the issue, confirmed that the system passed qas and is operating as expected.The fse reports that the system meets manufacturer specifications.No parts were returned so investigation will be limited.Logs were reviewed by hologic technical support and it was determined that the targets were lost due to the compression force going to zero and the subsequent attempts to obtain new targets showed unexpected results.The root cause is unknown, but the probable cause is user error.Conclusion: in conclusion, this complaint cannot be confirmed.The logs show that the user had the petite needle selected for a biopsy device, however; images provided suggest that the brevera needle was in the fired state or the user did not adjust the z-axis correctly as the z and y locations seen in the pre-fire images deviated from what was sent to the bcm (biopsy control module) from the system.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).Install date (b)(6) 2020 the complaint history was reviewed and there were no reported work orders, cases, or complaints related to a system failure prior to this complaint.Probable cause indicates a user error therefore a review of the dhr is not warranted.

• 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: 23232703
• Report Number: 3005496266-2025-00068
• Device Sequence Number: 8706717
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: (01)15420045505858(11)200317
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 01/13/2026

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?: Yes
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2020
• 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