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

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user site that during a affirm prone biopsy system, 3d patient exam on (b)(6) 2025, the procedure was aborted post-incision due to the z-axis not lining up properly after qas.The user site reported that they were unable to target properly and that the biopsy was rescheduled.A hologic field service engineer (fse) was dispatched to investigate the device.The fse checked all the targets of the device and was unable to reproduce the problem.The fse did a device calibration and verified the qas.The fse verified that the system is now operating according to manufacturer specifications.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user site that during an affirm prone biopsy system, 3d patient exam on (b)(6) 2025, the procedure was aborted post-incision due to the z-axis not lining up properly after qas.The user site reported that they were unable to target properly and that the biopsy was rescheduled.No parts/logs were returned/provided so investigation will be limited to risk assessment and complaint review a hologic field service engineer (fse) went on site and could not reproduce the problem given the targets the customer experienced issues with.As a precaution he performed the stx calibration and verified qas passed.No additional complaints for targeting have been reported by this customer since completion of service activities based on the limited information available, root cause is unknown, the probable cause is user error as several other use factors can contribute to targeting issues, including but not limited to, patient pull back and movement of the area of interest with lidocaine application.Conclusion: in conclusion this complaint cannot be confirmed.Based on the limited information available, root cause is unknown, the probable cause is user error as several other external factors can contribute to targeting issues, including but not limited to, patient pull back and movement of the area of interest.No further issues have been reported by the customer since the fse visit.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).As the most probable cause was user error, review of the dhr is not warranted.Review of the complaint history who no previous complaints related to this issue and no further complaints since field service was on site.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM, 3D
• Common Device Name: BREAST BIOPSY 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: ugo chibueze ; 445 simarano drive; marlborough, MA 01752
• MDR Report Key: 24135266
• Report Number: 3005496266-2026-00013
• Device Sequence Number: 10343976
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: (01)15420045506510(11)221220
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/21/2026

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: 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: 12/22/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown