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	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on june 18, a patient had a mammography procedure and when the patient positioned, the paddle released, she went over to the gantry and the gantry c-arm rotated a little without touching the system and lost power with an error vta 29:14.A field engineer examined the device and checked all fuses, connectors, and can bus connections behind the detector.Rebooted the unit and checked all switch assemblies for proper operation.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
It was reported that when taking a left medial lateral oblique (lmlo) image, the paddle released the patient and then rotated without touching the machine.The c-arm rotated independently without touching the equipment.The gantry flagged with a vta error.The field engineer (fe) checked all fuses, connectors, and controller area network (can) bus connection behind the detector.The system was rebooted, and all switch assemblies were checked for proper operation to resolve the issue.No patient or user injury was reported.A review of the device history showed that the issue returned on august 1st, 2024.The fe was dispatched to the customer site and found a missing jumper wire on the vta control board.The fe replaced the missing wire to resolve the issue.On (b)(6) 2024, the customer reported additional vta errors.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.The system was rebooted; therefore, 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 uncommanded 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 uncommanded c-arm movement.The complaint review identified the c-arm was original to the system therefore, the dhr was reviewed.There were no discrepancies noted that were related to potential causes for uncommanded motion.System product code: sdm-sys-6000-3d.Serial number: (b)(6).System manufacture date: may 9th, 2017.System installation date: (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: 19660985
• Report Number: 1220984-2024-00071
• Device Sequence Number: 15159197
• 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): 08/05/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/05/2025
• 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