MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA; INSTRUMENT, BIOPSY

Model Number EVIVA 0913-20

Device Problems Difficult to Open or Close (2921); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

During set up for a tomosynthesis guided breast biopsy, it was noticed that the saline was not running through the tubing into the needle.System set up again to attempt to get saline to flow through tubing, without success.It was identified, after multiple attempts, that the saline was not running through the tubing and the needle would not open.New needle system utilized and biomed contacted to check vacuum, after assessment no issue identified with vacuum.No adverse event identified.Fda safety report id# (b)(4).

• Brand Name: EVIVA
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC. ; marlborough MA 01752
• MDR Report Key: 10465141
• MDR Text Key: 204919467
• Report Number: MW5096312
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: EVIVA 0913-20
• Device Lot Number: 19K02RM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1