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

Model Number	BREVDRV
Medical Device Problem Codes	Failure to Obtain Sample (2533); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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 experienced a driver error.It is reported that the user stepped on the foot pedal to initiate the biopsy, and the driver error occurred immediately after, at which time the brevera device would not respond.Further reporting from the user indicates that the patient had to be rescheduled after the needle had already been inserted into the patient's breast.A field service engineer (fse) was dispatched to examine the device and determined that the device driver was the issue based on system logs and troubleshooting.The fse replaced the driver, tested the device and confirmed that the system is now functioning in accordance with manufacturer specifications.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: brief description: it was reported on august 6, 2025, that during a procedure, the brevera system and driver 2409-2029 began experiencing issues and an error code.The site attempted to reboot the system and reconnect the driver, but the issue was not resolved.The patient was rescheduled, and a hologic field service engineer (fse) was sent out to investigate.The fse confirmed the driver was faulty and replaced the driver.Proper system functionality was restored after replacing the driver.Patient impact was reported as they were rescheduled for another day and required a second incision, making this a reportable event to the fda.Initial evaluation: the device was returned to hologic for investigation.No damage could be seen on the brevera packaging.No damage can be seen on the exterior of the brevera driver.Investigation methods and findings: the brevera driver was placed on the laboratory brevera system and was able to successfully initialize and complete startup testing.Test samples were taken, and after the first sample, the system displayed a driver error; replace device driver.The driver was removed from the system, and the upper housing of the driver was removed so that the interior of the driver could be examined.It could be seen that the timing shaft had rotated and part of it was next to the outer cannula fork.This could potentially cause enough resistance to prevent the timing shaft from rotating in between samples, leading to the issues seen in the complaint.The timing shaft was manually rotated so that it was no longer jammed, and the driver was reinitialized.It once again passed testing but gave the same error after taking another sample.Looking into the driver showed the same issue with the timing shaft.The timing shaft was unjammed, and more test sampling was attempted.Three more samples could be taken before the same error occurred.Cause/root cause: testing of the driver followed by visual inspection after receiving an error code was able to confirm that the root cause of the issues seen in the complaint was the timing shaft being jammed with the cannula wear plates, preventing proper initialization and causing the errors seen in the complaint.After reviewing the complaint, discussing the case with a hologic service sustainment engineer, and examining a previous investigation into this type of issue, the cause of the jamming was determined to be the needle not firing its full length into the breast tissue.This root cause can be linked to insufficient spring force when firing into breast tissue causing excess drag and reducing needle travel velocity.As a result, the timing shaft can become jammed with the outer cannula fork and the wear plate, effectively blocking cam shaft rotation and preventing biopsy samples from being taken.Conclusion: based on the errors seen in the complaint and the inspection of the driver, the errors were caused by the needle not firing the full distance, and the cannula forks became jammed with the timing shaft.Conversations with service engineering indicated that based off the error experienced, it is likely that the needle did not fire its full distance, causing the cannula forks to be jammed with the timing shaft of the driver.Since the patient had to be rescheduled for an additional procedure due to an inability to retrieve biopsy samples, this was considered a reportable event to the fda.A new driver design has been created that will address the spring force issue.Post market quality will monitor the complaint data for this new driver design and look to see if trends for the driver being jammed are still occurring.Complaint confirmed: yes.Device history record (dhr) review: driver serial number: (b)(6) driver cycle count: 3,613 driver sku: brevdrv system serial number: (b)(6).Driver manufacture date: 9/16/2024.Driver installation date: 11/6/2024.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.No deviations are mentioned within the dhr.

• 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: 22940060
• Report Number: 1222780-2025-00472
• Device Sequence Number: 9892786
• Product Code: KNW
• UDI-Device Identifier: 15420045507760
• UDI-Public: (01)15420045507760(11)240916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/02/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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