MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number	SDM-SYS-6000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions 3d mammography system procedure on (b)(6) 2025, the user received several system errors, and the unit shut down.A field service engineer (fse) was dispatched to examine the equipment and found loose screws within the vta assembly, which prevented the system brake from functioning properly.The fse removed the loose screws, applied loctite to the threads and reinstalled the screws.The fse tested the system and confirmed that no additional errors were displayed.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a selenia dimensions 3d mammography system procedure on (b)(6) 2025, the user received several system errors, and the unit shut down.A field service engineer (fse) was dispatched to examine the equipment and found loose screws within the vta assembly, which prevented the system brake from functioning properly.The fse removed the loose screws, applied loctite to the threads and reinstalled the screws.The fse tested the system and confirmed that no additional errors were displayed.No patient or user injury was reported.Note: a follow-up with the fse clarified that the loose screws were only related to the drag clutch and not any other vta screws/bolts.No initial evaluation could be performed because no part was returned or replaced.The field service engineer (fse) found that the drag clutch had a loose set screw.This loose set screw allows the drive shaft to spin without the engaging the drag clutch¿s passive slowing of vertical movement, this may result in an uncommanded motion error.The drag clutch had been recently replaced on (b)(6) 2025, after a vta error was experienced on (b)(6) 2025 under a separate complaint.To troubleshoot this complaint, on (b)(6) 2025, the fse added loctite on the set screw to mitigate the chances of the set screw loosening.The vta error reoccurred on (b)(6) 2025, under a new separate complaint.The fse replaced the passive drag clutch with the electromagnetic brake.There have been no further complaints related to vta errors or uncommanded motion since the fse replaced the drag clutch with the electromagnetic brake.Due to the limited information provided and lack of part return, the root cause of the vta errors could not be determined.The probable cause is that the set screw loosened after being not fastened flush with the flat cutout of the drive shaft when the drag clutch was replaced on (b)(6) 2025.Conclusion: in summary, the probable cause is that the drag clutch set screw was not tightly fastened to the flat portion of the drive shaft and loosened to the point that the shaft spun freely; however, the root cause is unknown.Because there was no patient injury and the occurrence rate was very low, no capa is required.Future events will continue to be monitored and trended.Device history record (dhr) review: udi: (b)(4) sku: (b)(6), serial number: (b)(6), date of manufacture: 3/7/2023, installation date: (b)(6) 2023.Dhr review summary: because the impacted drag clutch was not original to the system, a dhr review was not performed.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 22418058
• Report Number: 3005496266-2025-00023
• Device Sequence Number: 21007532
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)230307
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: SDM-SYS-6000-3D
• Device Catalogue Number: SDM-SYS-6000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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