MAUDE Adverse Event Report: HOLOGIC INC. SELENIA DIMENSIONS 3D MAMMOGRAPHY SYSTEM

Model Number SELENIA DIMENSIONS

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A breast needle location procedure was performed with the c-arm in the 90-degree orientation.The needle was incorrectly placed two times.Movement in the needle localization crosshair attachment to the hologic selenia dimensions 3d mammography system may have occurred during the procedure.The radiologist determined that the needle was not accurately placed in the lesion, and informed the surgeon to remove the tissue 1 cam to the side of the needle.After our initial investigation, the attachment appears to have available movement when the c-arm is placed into positions other than 0-degree.The attachment can move approx 5mm from left to right at the 90-degree orientation.We observed the attachment can move when barely touched.If the attachment is moved, the coordinates will have slightly shifted on the breast changing the marked point and possibly creating incorrect coordinates.The mag stand moves as well but is more stationary when in use.A field engineer from hologic checked the system.He said all the systems are identical and that the crosshair needs to be touched very lightly.

• Brand Name: SELENIA DIMENSIONS 3D MAMMOGRAPHY SYSTEM
• Type of Device: SELENIA DIMENSIONS
• Manufacturer (Section D): HOLOGIC INC.; marlborough MA
• MDR Report Key: 7605257
• MDR Text Key: 111341761
• Report Number: MW5077879
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): N
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELENIA DIMENSIONS
• Device Catalogue Number: SDM-00001-3D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1