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

Model Number	SDA-SYS-3000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions procedure on (b)(6) 2024, the system displayed vta errors and the system went down.Uncommanded c-arm movement in vertical motion was reported.A field engineer examined the equipment and determined that the drag brake needed to be replaced to resolve the issue.The system met the manufacturer´s specifications.No patient or staff injury reported.
Additional Manufacturer Narrative
On june 13th, 2024, a selenia dimensions (serial number (b)(6)) entered an emergency stop state with the following error codes: vta 29:17, 29:23, 29:19, and 29:20 / pmc 38:24 / gen 25:17, 25:41.Vta 29:17 appears when there is unexpected vertical motion detected associated with the vta.This occurred during a patient exam / procedure; however, there was no alleged health consequence or impact to the patient or user.The user rebooted the system and was able to continue using it.A field service engineer (fse) re-installed the drag clutch.No part was returned, so no initial evaluation could be performed.Because no part was returned, the investigation will be limited.After the motor clutch replacement, there were no subsequent uncontrolled motion errors reported.Based on this, the probable cause was a motor clutch malfunction.The probable cause is that there was no motor clutch present on the system.It was previously removed by the field service engineer (fse) due to a customer complaint.The drag clutch [also known as the motor clutch] prevents the vta from drifting down.This mitigates the likelihood of uncommanded motion events.This motor clutch is the main component which was used by the fse to resolve the behavior.In summary, the probable cause is that there was no motor clutch present on the system; the root cause is unknown.The motor clutch was previously removed by the field service engineer (fse).The drag clutch prevents the vta from drifting down.This mitigates the likelihood of uncommanded motion events.A capa is not required for this incident as there was no alleged impact on the patient or user and because the risk level did not change.This behavior will continue to be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: system serial number (s/n): (b)(6), system sku: sda-sys-3000-3d, system date of manufacture: 3/21/2018, gantry serial number: (b)(6), gantry sku: asy-04160, gantry date of manufacture: 3/19/2018, gantry udi: (b)(4), installation date: (b)(6) 2018, date of incident: (b)(6) 2024.Dhr review: reviewed the dhr.There were no related discrepancies.

• 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: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102
• MDR Report Key: 19619949
• Report Number: 1220984-2024-00067
• Device Sequence Number: 8084649
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: (01)15420045505636(11)180319
• 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): 06/16/2025

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: SDA-SYS-3000-3D
• Device Catalogue Number: SDA-SYS-3000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2018
• 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