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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Codes	Device Emits Odor (1425); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, that a burning odor was noted during a selenia dimensions mammography systems, 3d procedure.It was also reported that when the c-arm was being moved by the customer using the left c-arm switches, the c-arm continued to move down without command after the switch was released.A field engineer was dispatched to examine the equipment and determine that the odor and the continued c-arm motion were due to the left side switches, which had stopped working.The field engineer replaced both the left and right c-arm switches and confirmed equipment functionality in accordance with manufacturer specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: on (b)(6), 2025, a customer observed a burning smell from a selenia dimensions ((b)(6)) coming from the left side control insert switch.When the customer removed their finger from the switch, the c-arm continued to move down.The switch then stopped working.There was no alleged patient injury or health consequences.The field service engineer (fse) replaced both left and right-side switches.The control inserts were scrapped on site, so further initial evaluation could not be performed.The control inserts were 757 days old at replacement.This behavior has not returned since the latest repair by the field service engineer (fse) on (b)(6) 2025.The probable cause of the uncommanded movement is due to a c-arm control insert failure.Further investigation could not be carried out as the part was not returned, so the root cause of the uncommanded motion or burning smell is unknown.Conclusion: in summary, the probable cause is a malfunction of the control insert (asy-01348s); the root cause is unknown.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.Device history record (dhr) review: (b)(4); sku: sdm-sys-9000-3d; (b)(6).Date of manufacture: 8/14/2017 dhr review summary: because the control inserts were previously replaced, a dhr review was not performed.

• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 21859611
• Report Number: 1220984-2025-00049
• Device Sequence Number: 12734775
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)170814
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/21/2025

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-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2017
• 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