MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM

Model Number ASY-10430

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

As of today, the investigation for this issue is in progress.A follow-up will be filed as needed.

Event Description

It was reported that when using the system drapes blood continues to get under the compression paddle."we have blood that we are not able to clean that is around the white label on the paddle." replacement paddles were sent to the customer.

Manufacturer Narrative

Due to an increased trend in drape complaints a design review was performed and it was determined that a design change would be implemented.This change was approved on 02/01/2019 and will reduce areas where blood can flow and access the table and components.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM, 3D
• Type of Device: BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 8229374
• MDR Text Key: 132507489
• Report Number: 1220984-2019-00004
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• PMA/PMN Number: K153486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASY-10430
• Device Catalogue Number: ASY-10430
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1