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	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on august 1, that a selenia dimension moved on its own when trying to do an exposure.A field engineer examined the device and could not reproduce the error but found a missing jumper wire on the vta control board.The field engineer added the missing jumper wire and readjust voltage and tested functionality.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
It was reported that the c-arm moves without command when attempting exposure and the gantry flags several error codes.The system was rebooted and the errors cleared until they occurred again.A field engineer (fe) examined the equipment and troubleshooted control voltages.A missing jumper wire on vta control board was replaced and its voltage was readjusted to 21.7vdc to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of the device history showed that the issue returned on (b)(6) 2024, the customer reported additional errors under a separate complaint.The fe went back to the customer site and identified an abrasion on the tomo brake wiring.The fe replaced the tomo brake and wiring harness to resolve the issue.A vta jumper wire was replaced, and the voltage was adjusted.No parts were returned for further investigation.Additionally, the tomo brake and wiring harness were not returned for further investigation.The tomo brake and wiring harness were 2,633 days old at the time of replacement.The parts were not returned for further investigation.A probable cause of the un-commanded motion is related to an issue with the tomo brake and wiring harness.Further investigation could not be performed as the parts were not returned.Due to the limited information provided and lack of part return, the root cause 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.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 un-commanded c-arm movement.The complaint review identified the c-arm was original to the system therefore, the dhr was reviewed.There were no discrepancies related to potential causes for un-commanded motion.System product code: sdm-sys-6000-3d, serial number: (b)(6), system manufacture date: 09may2017, system installation date: on (b)(6) 2017.Unique device identified (udi): (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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 20042582
• Report Number: 1220984-2024-00091
• Device Sequence Number: 15437265
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)170509
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2017
• 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