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

Model Number EVIVA_0913-12T

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2019

Event Type  malfunction  

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 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.

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
• Type of Device: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9573099
• MDR Text Key: 175056897
• Report Number: 1222780-2020-00007
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 25420045505336
• UDI-Public: (01)25420045505336(10)
• Combination Product (y/n): N
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1