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

Model Number BREVDISP09

Device Problems Failure to Obtain Sample (2533); Defective Device (2588)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/18/2023

Event Type  malfunction  

Event Description

During breast biopsy with needle placed in breast an error message transpired.The error stated there was a driver error and to call service.We aborted the biopsy and removed the biopsy device from the breast and switched to our back up unit.Biopsy was completed successfully.The patient did have an additional puncture in the breast due to the need of starting over and new placement of the new biopsy device.Hologic service was called and came into service the device and determined it was a defective disposable biopsy needle.The biopsy unit was determined to not be at fault and is usable immediately.The disposable needle had been disposed of.

• Brand Name: BREVERA BREAST BIOPSY SYSTEM
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlborough MA 01752
• MDR Report Key: 17324786
• MDR Text Key: 319025782
• Report Number: 17324786
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• 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: 23A27RD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2023
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 07/14/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female