MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number	SDM-SYS-6000-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions mammography system procedure on (b)(6) 2025, the user was utilizing a switch on the unit to rotate the c-arm and the c-arm continued rotating after the switch was released.A field engineer was dispatched to assess the unit, ordered new c-arm switches and installed the new switches on the system.The field engineer indicates that the system is now working in accordance with manufacturer specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
It was reported that the c-arm rotated into a chair and blew a fuse.The technician was rotating the c-arm, and it kept going after the rotation switch was released.A field engineer (fe) examined the equipment and found that the control inserts were likely sticking.The fe replaced the control inserts to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of this device history showed that the issue of uncommanded c-arm movement did not return after the control inserts were replaced.It was noted that the control inserts and rotary switch were replaced on (b)(6) 2025, due to an issue with the buttons.The c-arm control inserts were replaced; however, no parts were returned for further investigation.The control inserts were 1665 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 related to natural wear and tear on the component due to the component age of 1665 days.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 inserts 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 probable cause of the uncommanded movement is due to an issue with the control inserts.Additionally, the risk is considered very low based on the occurrence.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a review of the complaint history for (b)(6) showed no additional complaints for uncommanded c-arm movement related to the control inserts.It was noted that the control inserts and rotary switch were replaced on (b)(6) 2025.The complaint review identified the control inserts were original to the system therefore, the dhr was reviewed.There were no discrepancies noted in the dhr.The control inserts were installed on this gantry with no issues noted.System product code: sdm-sys-6000-2d.Serial number: (b)(6).System manufacture date: november 5th 2020.System installation date: (b)(6) 2020.Unique device identified (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Common Device Name: FULL FIELD DIGITAL 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: 22214174
• Report Number: 3005496266-2025-00021
• Device Sequence Number: 8131712
• Product Code: MUE
• UDI-Device Identifier: 15420045510753
• UDI-Public: (01)15420045510753(11)201105
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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-6000-2D
• Device Catalogue Number: SDM-SYS-6000-2D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2020
• 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