MAUDE Adverse Event Report: HOLOGIC, INC. BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY; BIOPSY INSTRUMENT

Model Number	BREV09
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that during retracting the biopsy needle the sleeve of the introducer distorted and a hole was noted in the sleeve.No injury reported.The user succeeded in placing the needle and the marker in the area that was biopsied.

• Brand Name: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11893407
• Report Number: 1222780-2021-00130
• Device Sequence Number: 11689821
• Product Code: KNW
• UDI-Device Identifier: 15420045507777
• UDI-Public: 15420045507777
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: BREV09
• Device Catalogue Number: BREV09
• Device Lot Number: 10728490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1