MAUDE Adverse Event Report: HOLOGIC, INC. BREVERA BREAST BIOPSY SYSTEM; INSTRUMENT, BIOPSY

Model Number	BREVDISP09
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Nothing unusual happened during the procedure; however, on post-procedure imaging, an artifact was noted.At that point, the device (needle) was examined and appeared abnormal.The brevera machine operates fine, no errors (checked out by hologic).It was the disposable needle that appeared broken.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 22849596
• Report Number: 22849596
• Device Sequence Number: 19938154
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)270222(10)25B22RC
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 08/15/2025

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
• Device Model Number: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 25B22RC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Date Report Sent to FDA: 08/15/2025