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	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on january 23rd, 2025, jerky tomo motion was observed on a selenia dimensions 3d.A field engineer assessed the machine and found loose tomo bolts.During the repair and replacement of the bolts, it was found that one of the old bolts had broken off within the vertical travel assembly (vta).As a result, the vta was replaced entirely.The field engineer completed all necessary repairs and calibrations, and the device is now functioning in accordance with manufacturers specifications.No patient or user injury reported.
Additional Manufacturer Narrative
An investigation was completed: on 1/14/2025, it was reported that the system was making noise and jerking during tomo motion.The field engineer (fe) was dispatched to the customer site and found two loose bolts on the vertical travel assembly.The fe attempted to resolve the issue by replacing the bolts, however during the replacement one of the old bolts broke off within the assembly.The fe replaced the vta assembly to resolve the issue.No patient or user injuries were reported.A review of the device history showed this issue has not recurred since the part was replaced.The vta bolts were on the system for 2,673 days and were not returned for further investigation.The cause of the system shaking was due to loose vta bolts.A capa has been opened to investigate the root cause of the loose/broken vta bolts.Conclusion: this investigation will be closed and the root cause investigation for this issue will be documented in the capa.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a review of the complaint history for (b)(6) was performed and no additional complaints related to loose vta bolts were found.The complaint review identified that the vta and bolts were original to the system therefore, the dhr was reviewed.There was no discrepancy related to the vta assembly.The vta was installed on this gantry with no issues noted.System product code: sdm-sys-6000-3d.Serial number: (b)(6).Manufacture date: 9/18/2017.System installation date: 9/29/2017.Unique device identifier: (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 21763314
• Report Number: 1220984-2025-00034
• Device Sequence Number: 8463471
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)170918
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 09/18/2025

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: 01/23/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2017
• 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