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

Model Number	BREVDISP09
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported by the user that during a brevera breast biopsy procedure on (b)(6) 2025, "the biopsy needle did not take samples, and suction did not work.No error on brevera machine." additional information was received from the user site in which it was reported, "technologist tried to figure out what was wrong with system in that time patient passed out and radiologist took needle out.The procedure was cancelled, and we had to call 911." it is reported that the patient was assessed and taken to the emergency department.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported by the user that during a brevera breast biopsy procedure on (b)(6) 2025, "the biopsy needle did not take samples, and suction did not work.No error on brevera machine." additional information was received from the user site in which it was reported, "technologist tried to figure out what was wrong with system in that time patient passed out and radiologist took needle out.The procedure was cancelled, and we had to call 911." it is reported that the patient was assessed and taken to the emergency department.Visual inspection was conducted, and there were no signs of physical damage or visual defects.As additional information, the bearing, gears and all the tubing connections were inspected, and no issues were found.Functional testing was conducted, and the device was tested and passed the set-up and test phases, was able to retrack and fire, and completed the 12 cycles of cut as intended, no strange behavior or malfunction were detected during the test.Also, the tissue acquisition test was performed, and the device was able to retrieve all the samples and was able to fill out the chambers with cores without issues.Hence, the complaint cannot be confirmed.This observation will be monitored and trended.

• 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: 24165798
• Report Number: 1222780-2026-00032
• Device Sequence Number: 15765966
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863(17)270509(10)25E09R
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/11/2026

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: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 25E09R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown