MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

Model Number	SDA-SYS-3000-2D-HTC
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On the 2nd of september 2024, our customer reported an incident with our selenia dimensions mammography system.It was reported that a vta 29:17 on 2nd of september 2024, a field service engineer confirmed that c-arm moved slightly up/down direction without any command.The incident occurred during the procedure.No injury was reported to the user/staff.On the 2nd of september 2024, the field engineer visited the site to examine the system for vta 29:17 error, checked the mechanical parts of the vertical travel assembly (vta), and found that the motor clutch was defective.The defective clutch has been replaced.The system was extensively tested and is now operating according to specifications.
Additional Manufacturer Narrative
An investigation was completed: on 2nd of september 2024, our field service engineer confirmed that c-arm moved slightly up/down direction without any command.The incident occurred during the procedure.No injury was reported to the user/staff.On 2nd of september 2024, our hologic field engineer visited the site to examine the system.Our hologic field engineer checked the mechanical parts of the vertical travel assembly (vta) and found that the motor clutch is defective.The clutch is designed and meant to prevent uncommanded motions of the c-arm.Our hologic field engineer confirmed the cause of this incident is a defective vta clutch.The defective clutch has been replaced.The system was extensively tested and is now operating according to specifications.The motor clutch was sent to recycling and was not returned for further investigation.The motor clutch was 2,277 days old.It was the initial part during assembly.Because no part was returned, the investigation will be limited.The root cause is unknown due to the unreturned part.The probable cause is that the motor clutch malfunctioned.Conclusion: in summary the root cause is unknown, the probable cause is a malfunction of the motor clutch.This was resolved through replacement using the newer assembly kit.A capa is not needed at this time as there was no patient or user harm and because the risk is considered low based on the occurrence.Future events will be monitored and trended device history record (dhr) review: udi: (b)(4), sku: (b)(4), serial number: (b)(6), date of manufacture: 11/05/2018 , installation date: (b)(6) 2018, incident date: (b)(6) 2024.Dhr summary: there were no discrepancies in the dhr related to uncommanded/uncontrolled motion.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 20237945
• Report Number: 1220984-2024-00111
• Device Sequence Number: 12928475
• Product Code: MUE
• UDI-Device Identifier: 15420045510616
• UDI-Public: (01)15420045510616(11)181105
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P010025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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
• Operator of Device: Health Professional
• Device Model Number: SDA-SYS-3000-2D-HTC
• Device Catalogue Number: SDA-SYS-3000-2D-HTC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown