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

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an affirm prone procedure on (b)(6) 2025, the needle went 3cm past the intended target.No patient or user injury was reported.Hologic technical support reviewed the system logs and found the pre-fire image showed that the needle tip was not at the target.Additionally, in reviewing the system logs, it appeared that the needle in the images did not match the needle that was selected.A hologic field service (fse) was also dispatched to examine the system.The fse ran quality checks, which the system passed with no issues found.Further, the fse performed several calibration checks, which were also successful, and passed with no issues.The fse reports that the system meets all manufacturing standards.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during an affirm prone procedure on (b)(6) 2025, the needle went 3cm past the intended target.No patient or user injury was reported.Hologic technical support reviewed the system logs and found the pre-fire image showed that the needle tip was not at the target.Additionally, in reviewing the system logs, it appeared that the needle in the images did not match the needle that was selected.A hologic field service (fse) was also dispatched to examine the system.The fse ran quality checks, which the system passed with no issues found.Further, the fse performed several calibration checks, which were also successful, and passed with no issues.The fse reports that the system meets all manufacturing standards.No parts/system were returned so investigation will be limited to complaint review and risk assessment.The complaint was reviewed and based on the case notes provided by 2nd level technical support it appears the customer selected the wrong needle in use.The logs verified that the needle did miss the target but the pre-fire & post fire images suggested the customer was using a ¿trocar¿ needle when they had the ¿brevera¿ needles selected as it was the biopsy device last loaded to the bcm display at 8:29:57am.The hologic field engineer went on site and prior to any calibration was able to successfully run the qas test and pass.In an abundance of caution the fse performed compression calibration, performed stx calibration, and tested system by performing qas test again.No issues were found, and the system was returned to the customer.Root cause is unknown, but probable cause is use error.Conclusion: in conclusion the complaint cannot be confirmed.The logs and images provided suggest the customer selected the wrong needle leading to the targeting issues.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).Serial number: (b)(6) sku: pbx-sys-affirm-3d manufacture date: 7/13/2018 install date: (b)(6) 2018 the complaint history was reviewed and no issues with targeting have been noted previously.A review of the dhr was performed and no discrepancies related to targeting were noted.The system passed all manufacturing tests associated with targeting.

• 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: 23143045
• Report Number: 3005496266-2025-00061
• Device Sequence Number: 9856887
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: (01)15420045506510(11)180713
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/20/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2018
• 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