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

Model Number SDM-00001-2D

Device Problem Unintended System Motion (1430)

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

Event Date 12/28/2021

Event Type  malfunction  

Event Description

It was reported that the tilt button on the gantry was not working correctly and moves on its own.No injury reported.A field engineer was dispatched to the site and determined the c-arm switches and rotational switch needed to be replaced.While onsite the customer also reported having issues with footswitch response and the foot switches were replaced as well.Once this was completed the system was working as intended.

Manufacturer Narrative

The foot switches, rotation switch, and c-arm switches were returned to hologic for evaluation.Functional check on the returned parts identified that the foot switches showed signs of usage and wear.The switch buttons were loose and required excess pressure to command the c-arm movement.The rotation and c-arm switches were operating as intended.A definitive root cause cannot be determined as the issue with the tilt button could not be duplicated.Hologic strives for continuous improvement and will continue to monitor and trend for safety.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 13291704
• MDR Text Key: 285496608
• Report Number: 1220984-2022-00003
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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: SDM-00001-2D
• Device Catalogue Number: SDM-00001-2D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 12/28/2021
• Supplement Dates FDA Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1