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

Model Number	BREVDISP09
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the user site observed possible foreign material in the acquired tissue specimen.The user site confirmed via post procedure imaging and pathology that no foreign material was left in the patient's breast.No further information is currently available.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the user site observed possible foreign material in the acquired tissue specimen.The user site confirmed via post procedure imaging and pathology that no foreign material was left in the patient's breast.The device was not returned for this complaint, and only photographic evidence is available; therefore, a full investigation could not be conducted.Due to the severity of the harm associated with the brevera disposable device and the identified issue of "foreign matter / foreign material in or on device," a capa has been initiated to address this matter.The investigation, including root cause analysis, was conducted under the capa.Conclusion: the reported issue could not be confirmed because the device was not returned.The cause will be further investigated and addressed in the capa for brevera handpiece (brevdisp09) foreign material reported in patients and in specimen collection tray.The risks associated with this complaint event are further described and evaluated against the product and its hazard analysis in the health risk assessment (hra) for brevera foreign material / metal fragments issues.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: the dhr was reviewed for the corresponding lot, and no manufacturing issues or relevant risk factors related to the analyzed failure mode were identified.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23704665
• Report Number: 1222780-2025-00607
• Device Sequence Number: 10595885
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)270801(10)25H01RP
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163052
• 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): 02/12/2026

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: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 25H01RP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown