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

Model Number SEL-00015

Device Problem Unintended System Motion (1430)

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

Event Date 04/19/2021

Event Type  malfunction  

Event Description

It was reported that when moving the unit down and releasing the footswitch the unit continues to move.No injury reported.A field engineer was dispatched to the site and determined the footswitch needed to be replaced.Once this was completed the system was working as intended.

Manufacturer Narrative

The reported footswitch was returned to hologic for investigation and a visual and functional evaluation was performed.Visual evaluation of the returned part indicates that the c-arm pedal is detached (broken) from the compression pedal.The switches appear dirty, and worn out.The switches work as per the specification when manually held together.The broken section causes imbalance between the two controllers, resulting in possible sticking of the switches and uncommanded motion.This part was last replaced on (b)(6) 2019.

• 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: 11845790
• MDR Text Key: 252405421
• Report Number: 1220984-2021-00011
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): Y
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: Health Professional
• Device Model Number: SEL-00015
• Device Catalogue Number: SEL-00015
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/18/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1