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

Model Number	BREVDISP09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Maude report (b)(4).
Event or Problem Description
It was reported that during a brevera procedure on (b)(6) 2023, a small sliver of plastic was shaving off the cut block and was located in the patient's tissue.It was reported that this occurred on another patient later on that month and the customer reported a third piece of plastic found in patient tissue the end of the next month.No further information is available at this time.
Additional Manufacturer Narrative
Maude report: (b)(4).
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a brevera procedure on (b)(6) 2023, a small sliver of plastic was shaving off the cut block and was in the patient's tissue.It was reported that this occurred on another patient later that month and the customer reported a third piece of plastic found in patient tissue at the end of the next month.No further information is available.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event the device was not returned for this complaint, and only limited patient-related information was provided.Therefore, a full investigation could not be conducted.Without the returned sample, it is not possible to confirm a definitive root cause of the issue it was not possible to confirm that the brevera disposable directly caused the reported harm.However, based on the severity of the harm and cases related to ¿foreign matter | foreign material in / on device¿ the complaint has been escalated.A corrective action has been initiated to address the issue, and the investigation, including root cause analysis, will be 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 a capa.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).Future events will be monitored and trended.Device history record (dhr) review: the dhr review was not conducted since the lot/serial number was not provided by the complainant.Maude report: (b)(4).

• 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: 22036105
• Report Number: 1222780-2025-00259
• Device Sequence Number: 8476130
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: 15420045512863
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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
• Device Model Number: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided; 11/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/24/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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