MAUDE Adverse Event Report: HOLOGIC, INC EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
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.If the device is returned and 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 when the biopsy was done and as the tubing was moved, "the specimen container opened freely (as if it had not been re-closed / locked) and of course any remaining fluid - saline & blood was spilled to clothing, floor, vacuum equipment.This is the 3rd time it has happened with the petite needle." no additional details available.
Additional Manufacturer Narrative
The device was received for investigation but it could not be tested for reported complaint because the device tubing was cut off of the device prior to being received.Functional testing was not performed, therefore, the complaint could not be verified.This observation will be monitored and trended.

• Brand Name: EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9573099
• Report Number: 1222780-2020-00007
• Device Sequence Number: 19680320
• Product Code: KNW
• UDI-Device Identifier: 25420045505336
• UDI-Public: (01)25420045505336(10)
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 09/08/2021
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 19J09RD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1