MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number SEL-00001

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Event Description

It was reported that intermittently the c-arm rotation is not stopping when using the auto position switches and continuing to rotation past the desired position.No injury was reported.A field engineer has been dispatched to the site.The investigation is still in progress.

Event Description

The field engineer was not able to reproduce the reported issue.The system is working to hologic specifications and the customer has not reported any additional issues.

• Brand Name: SELENIA MAMMOGRAPHY SYSTEM
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 11952256
• MDR Text Key: 263527360
• Report Number: 1220984-2021-00017
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEL-00001
• Device Catalogue Number: SEL-00001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1