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	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions 3d patient procedure on (b)(6) 2025, the c-arm continued to move in a downward motion after the foot pedal was released by the user.A field engineer was dispatched to examine the system and confirmed the user's observation.The field engineer replaced the foot pedal and confirmed that the system is functioning in accordance with manufacturer specifications.No patient/user injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a selenia dimensions 3d (serial number (b)(6)) patient procedure on (b)(6) 2025, the c-arm continued to move in a downward motion after the foot pedal was released by the user.A field engineer was dispatched to examine the system and confirmed the user's observation.The field engineer replaced the foot pedal and confirmed that the system is functioning in accordance with manufacturer specifications.No patient/user injury was reported.This part was scrapped on site, so no initial evaluation could be performed.The footswitch was 1,192 days old at the time of replacement.Because the part was unavailable for investigation, a complaint review was performed.Review of the complaints showed that there were no other complaints related to uncontrolled motion or footswitches prior to or since this incident.The probable cause is a stuck footswitch pedal.The footswitch was not returned; therefore, further investigation could not be carried out.Due to the limited information provided and lack of part return, the root cause of the failure could not be determined.Conclusion: 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.Because of this, and because there was no severe injury, no capa is required.This will continue to be trended and monitored.Device history record (dhr) review: udi: (b)(4), sku: sdm-sys-6000-3d, serial number: (b)(6), date of manufacture: 3/19/2018, installation date: 4/9/2018, incident date: 6/24/2025, closest pm to complaint date: 1/24/2025, date of part manufacture: unknown ¿ this information was not obtained prior to scrapping.Dhr review summary: the footswitch that failed was a previous replacement (not original to the system), so a dhr review was not required.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 22532306
• Report Number: 3005496266-2025-00031
• Device Sequence Number: 20788252
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)180319
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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-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: 06/24/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2018
• 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