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

Model Number	BREVDRV
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a brevera breast biopsy procedure on (b)(6) 2025, the user site experienced a system driver error.It is reported that the radiologist targeted and fired the device into the patient's breast but then decided to remove the needle and retarget when the device error occurred.The user site reports that the needle remained in the patient's breast while attempting to obtain support from hologic technical support; however, the user eventually decided to remove the needle, and the procedure was not completed.A hologic field service engineer (fse) was dispatched to examine the device and review system logs.The fse found that the error occurred when the system prompted that the introducer was not installed.A petite introducer was installed in the incorrect mode, then removed, also in the incorrect mode, which generated a "needle disconnected in biopsy" and "device driver armed in invalid state" system errors.The fse restarted the device, cleared the errors, and performed system tests with the existing device driver.The fse reports that no system issue was found, the system passed all tests and meets manufacturer specifications.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: brief description: it was reported on 11/13/2025 that during a procedure, the brevera driver (b)(6) and brevera system began experiencing error, ¿motor fault during biopsy arm¿, interrupting the procedure.System logs were reviewed and it was seen that the following messages were displayed: introducer not installed, petite introducer installed in incorrect mode, then removed in wrong mode and, device driver armed in invalid state.System was restarted and the error was cleared.The system was returned to the customer for use.Initial evaluation: neither the driver nor console was returned to hologic pmqa for evaluation.The driver had been in use for approximately 1 year and 9 months at the time of the complaint.Investigation methods and findings: since no parts were returned to hologic pmqa, an investigation could not be carried out.Cause/root cause: since no full investigation could be carried out, a definitive root cause could not be determined.Based on the details of the complaint, the error codes listed, and discussions with a service engineer, the most probable root cause was an issue installing the needle resulting in the driver being unable to fully arm.This could be caused by the gear on the needle sitting behind the ic fork instead of inside of it, preventing the driver from completely arming.Conclusion: on (b)(6) 2025, the customer stated that they received an error code, which indicates a motor fault during the arming sequence.During troubleshooting, they also encountered numerous errors with introducers and needles being installed and removed incorrectly and in the wrong mode.The issue was resolved by rebooting the system and reseating the needle.Complaint confirmed: no.Device history record (dhr) review: driver serial number: (b)(6).Driver sku: brevdrv.Driver manufacture date: 8/14/2023.Udi: (b)(4).The device history record for the serial number involved was reviewed and was found to have met all manufacturing requirements prior to shipment for distribution.This includes final inspection and packaging inspections.

• 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: 23705962
• Report Number: 1222780-2025-00611
• Device Sequence Number: 18808974
• Product Code: KNW
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/01/2026

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: BREVDRV
• Device Catalogue Number: BREVDRV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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