MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 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	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions procedure on (b)(6) 2025, the tech reported that the unit was noisy and that she heard an unusual noise from the gantry and that the c-arm moved past the commanded motion.A field engineer examined the equipment and couldn´t replicate the issue.The field engineer greased the plastic on tube covers and tested with 10 combo shots and the system met the manufacturer´s specifications.No other information available.
Additional Manufacturer Narrative
On (b)(6) 2025, a customer reported that there was uncommanded motion on a selenia dimensions (serial number (b)(6).There was also a complaint of an unusual noise from the gantry.There was no alleged health consequence or impact to the user/patient.The field service engineer (fse) could not replicate the issue.To troubleshoot, grease was applied to the tube covers and various test shots were taken without issue.No part was returned, so no initial evaluation could be performed.Further investigation could not be performed as the parts were not returned.The probable cause is that a c-arm rotation button malfunctioned causing uncommanded rotation.The root cause is unknown.Conclusion: in summary, the probable cause is a c-arm switch malfunction.This part was replaced by service and the behavior has not returned since.The root cause is unknown.A capa is not required for this incident as there was no alleged impact to patient or user and because the risk level did not change.This behavior will continue to be monitored and tracked in the future.Complaint confirmed: no device history record (dhr) review: udi: (b)(4), sku: sdm-sys-6000-3d, serial number: (b)(6), date of manufacture: 3/1/2016, installation date: (b)(6) 2016, incident date: 1/7/2025, closest pm to complaint date: (b)(6) 2024, date of part manufacture: unknown.Because both control switches (controls insert) were previously replaced, a review of the gantry dhr file is not required.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21315557
• Report Number: 1220984-2025-00009
• Device Sequence Number: 8019952
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)160301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/17/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2016
• 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