MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT

Model Number	EVIVA_0913-20
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been 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 a biopsy procedure, a sample wasn't able to be collected and the needle was stuck in the patient breast.When the needle was removed from the breast it was noted that the sheath was completely wrinkled.The patient had pain while removing the needle, no injury reported.
Additional Manufacturer Narrative
The reported device was returned for testing.Visual inspection confirmed the reported issue, the introducer appeared wrinkled, damaged, and unsnapped from the device.Tissue acquisition testing was performed with a new introducer and the device worked as intended with no introducer damage during the procedure.

• Brand Name: EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11417840
• Report Number: 1222780-2021-00040
• Device Sequence Number: 3815674
• Product Code: KNW
• UDI-Device Identifier: 15420045505889
• UDI-Public: 15420045505889
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 12/04/2021
• Device Model Number: EVIVA_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: 19M05RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1