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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a patient exam on (b)(6) 2025, the right-side gantry function buttons on a selenia dimensions mammography system were intermittently sticking.A field service engineer (fse) was dispatched to assess the device and confirmed the reported findings.The fse replaced the left and right gantry function key panels, verified all gantry function control buttons respond as expected and that the flat field combo image worked as expected.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that prior to a patient exam on (b)(6) 2025, the right-side control insert buttons on a selenia dimensions system were intermittently sticking.A field service engineer (fse) examined the equipment and replaced the left and right control inserts to resolve the issue.No patient or user injury was reported.A review of this device history showed that under a separate complaint, on (b)(6) 2025, the control inserts were replaced.However, this replacement was due to vta errors and was not related to uncommanded c-arm movement.The issue of uncommanded c-arm movement did not return after the control inserts were replaced.The control inserts were 98 days old at the time of replacement.The part was not returned for further investigation.The probable cause of the uncommanded movement is due to an issue with the control inserts.The likely cause is unknown as the part was 98 days aged at replacement.Further investigation could not be performed as the part was not returned.Due to the limited information provided and lack of part return, the root cause of the control insert failure could not be determined.Conclusion: based on a review of the complaint, a capa is not needed at this time as there was no patient or user harm.The root cause of the failure could not be determined.The risk level did not change and is considered very low based on the occurrence.Future events will be monitored and trended.Device history record (dhr) review: a review of the complaint history for (b)(6) showed the control inserts were replaced on the system on (b)(6) 2025, under a separate complaint.The reason for the replacement was unrelated to uncommanded c-arm movement.There were no additional complaints for uncommanded c-arm movement related to the control inserts.The complaint review identified that the control inserts were not original to the system therefore, the dhr was not reviewed.System product code: sdm-sys-9000-3d.Serial number: (b)(6).System manufacture date: 25jan2018.System installation date: (b)(6) 2018.Unique device identified (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: 22967203
• Report Number: 3005496266-2025-00053
• Device Sequence Number: 21113442
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)180125
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/29/2025

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-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2018
• 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