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

Model Number BREVDISP09

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2022

Event Type  malfunction  

Event Description

Biopsy needle was found to be defective after failing preprocedural testing sequence.Equipment checks and adjustments were made per manufacturer suggestions.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 16263934
• MDR Text Key: 308369476
• Report Number: 16263934
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045512863
• UDI-Public: (01)15420045512863
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BREVDISP09
• Device Catalogue Number: BREVDISP09
• Device Lot Number: 22G24RG
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female
• Patient Weight: 78 KG