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	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the c-arm on a selenia dimensions mammography systems, 3d, moved without command to its lowest position during a procedure.A field engineer was dispatched to assess the equipment and determined that the foot switch became stuck, causing the c-arm to move down.The field engineer replaced both foot switches and hand switches and confirmed that the equipment is now functioning at manufacturers specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
On (b)(6) 2024, a customer reported that the c-arm on their selenia dimensions (serial number (b)(6)) traveled to its lowest point without user input.There was an error indicating a stuck footswitch.The field service engineer (fse) replaced both footswitches and the control inserts.The fse then verified that the c-arm moves and stops as expected.The part was scrapped on site.Because of this, there was no part returned, and no initial evaluation performed.The part was 2828 days old upon replacement.A review of the device history showed that the behavior did not recur since this complaint.Further investigation could not be performed as the parts were not returned.Based on the stuck footswitch error code, the probable cause of the uncommanded movement is due to an issue with the footswitch.Possible causes for footswitch issues include wear and tear due to part use or debris accumulation due to its location on the floor.The footswitch was not returned; therefore, further investigation could not be performed.Due to the limited information provided and lack of part return, the root cause of the failure could not be determined.The probable cause is a stuck footswitch; the root cause is unknown due to the unreturned part.The severity for this incident is very low, and the calculated post risk control risk index is considered acceptable.Because of this, and because there was no severe injury, no capa is required.This will continue to be trended and monitored.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4).System sku: sdm-sys-6000-3d.System serial number: (b)(6).System date of manufacture: 1/18/2017.Installation date: (b)(6) 2017.Incident date: (b)(6) 2024.Date of part manufacture: unknown.Dhr review: there were no discrepancies related to footswitches or uncommanded motion.

• 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: 21840356
• Report Number: 1220984-2025-00041
• Device Sequence Number: 18317495
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)170118
• 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): 06/30/2025

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: 10/29/2024
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2017
• 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