MAUDE Adverse Event Report: HOLOGIC, INC 3DIMENSIONS; MAMMOGRAPHY SYSTEM

Model Number	3DM-SYS-STD
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a customer experienced error codes on a 3dimensions mammography system causing the system to shut down.A field engineer was dispatched to examine the equipment and found the error codes were caused by the c-arm continuing to move after the c-arm side switch was released, causing uncommanded c-arm motion.The field engineer replaced a system brake as well as the c-arm switches.The field engineer tested the system to ensure that the system is now functioning in accordance with manufacturer specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was completed: it was reported that vta ¿uncommanded vertical motion¿ error tripped when the c-arm was moving downward.Error logs showed the c arm moved after the control insert switches were released.A field engineer examined the equipment, and it was noted that the control inserts were broken on one side of the gantry.The fe replaced the vta motor clutch and the c-arm control inserts to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of this device history showed that the issue did not return after vta motor clutch and the c-arm control inserts were replaced.The c-arm control inserts and motor clutch were replaced; however, no parts were returned for further investigation.The control inserts and motor clutch were 785 days old at the time of replacement.The parts were not returned for further investigation the probable cause of the uncommanded movement is due to an issue with the control inserts.The likely cause is related to natural wear and tear on the control inserts.Further investigation could not be performed as the part was not returned.Due to the limited information provided and lack of part return, the root cause of the control insert failure could not be determined.Conclusion: 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.Complaint confirmed: no.Device history record (dhr) review: a review of the complaint history for (b)(6) showed no additional complaints for uncommanded c-arm movement related to the control inserts.The complaint review identified the control inserts were original to the system therefore, the dhr was reviewed.There were no discrepancies related to the control inserts.The control inserts were installed on this gantry with no issues noted.System product code: 3dm-sys-std.Serial number: (b)(6).System manufacture date: 01mar2023.System installation date: 30mar2023.Unique device identified (b)(4).

• Brand Name: 3DIMENSIONS
• 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: 21954207
• Report Number: 3005496266-2025-00001
• Device Sequence Number: 12569501
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)230301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/15/2025

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: 3DM-SYS-STD
• Device Catalogue Number: 3DM-SYS-STD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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