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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Facility information is unknown.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.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 the procedure, "when the needle was dialed down into the breast the sheath would scrunch up." no known impact to patient.

• Brand Name: BREVERA BIOPSY SYSTEM WITH CORLUMINA IMAGING TECHNOLOGY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough, ma
• MDR Report Key: 9924261
• Report Number: 1222780-2020-00073
• Device Sequence Number: 14276979
• Product Code: KNW
• UDI-Device Identifier: 15420045507777
• UDI-Public: (01)15420045507777(17)200815(10)6622390
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 08/15/2020
• Device Model Number: BREV09
• Device Catalogue Number: BREV09
• Device Lot Number: 6622390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1