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

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the chamber holding the local anaesthetic would not hold in place and the saline did not flush through the system during the procedure.These issues resulted in the patient not receiving adequate local anaesthetic and may have caused a larger amount of hematoma at the biopsy site.The biopsy site was not able to be flushed with saline during lavage which caused the biopsy marker to move from the biopsy site.Attempts to obtain additional information were unsuccessful.
Event or Problem Description
Additional information received from the customer confirmed that the biopsy was completed with some discomfort to the patient and no medical intervention was required.

• 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: 11289755
• Report Number: 1222780-2021-00026
• Device Sequence Number: 3440312
• Product Code: KNW
• UDI-Device Identifier: 15420045505889
• UDI-Public: 15420045505889
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 11/24/2021
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 19L25RA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1