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

Catalog Number EVIVA 0913-20

Device Problem Failure to Advance (2524)

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

Event Date 02/19/2016

Event Type  malfunction  

Event Description

When testing probe before biopsy, tech noticed that the cutter was not advancing like it should.Didn't use it.

• Brand Name: EVIVA BIOPSY DEVICE
• Type of Device: STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC. ; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 5529195
• MDR Text Key: 41337885
• Report Number: MW5061278
• Device Sequence Number: 1
• Product Code: IZH
• Reporter Country Code: US
• 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: 03/10/2016

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
• Device Operator: No Information
• Device Expiration Date: 10/05/2017
• Device Catalogue Number: EVIVA 0913-20
• Device Lot Number: 15K06RB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR