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	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, that system shaking was observed during a selenia dimensions mammography systems, 3d procedure.A field engineer was dispatched and found loose bolts within the system.The field engineer replaced the loose hardware, completed system calibrations and confirmed that the system is operating to manufacturer specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was completed: on (b)(6) 2025, it was reported that the gantry was shaking during tomo sweep.The field engineer (fe) was dispatched to the customer site and found loose vertical travel assembly (vta) bolts.The fe replaced the vta bolts 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 2,617 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.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.Device history record (dhr) review: a review of the complaint history for (b)(6) was performed and no additional complaints related to lose vta bolts were found.The complaint review identified that the vta and bolts were original to the system therefore, the dhr was reviewed.There were no discrepancies noted in the dhr.The vta was installed on this gantry with no issues noted.System product code: sdm-sys-6000-3d, serial number: (b)(6), manufacture date: 3/16/2018, system installation date: (b)(6) 2018, unique device identifier (udi): (b)(4).

• 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: 22132688
• Report Number: 3005496266-2025-00013
• Device Sequence Number: 8526459
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)180316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2018
• 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