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	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, that the right-side switches on a 3dimension's mammography system were not working.The customer attempted shutting off the system and wiggling the switches, but the issue continued.A field engineer was dispatched to examine the equipment and determined that the switches were intermittently not responding or following wrong commands.The field engineer replaced the c-arm switches, tested all switch system functions and confirmed that the system is now functioning in accordance with the manufacturers specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
An investigation was completed: it was reported that the right-hand c-arm control inserts were not working correctly.The c-arm was intermittently not responding or following wrong commands.A field engineer (fe) examined the equipment and found that the control insert switches felt loose and were not making correct contact with the pcb.The fe replaced the 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 the control inserts were replaced.The c-arm control inserts were replaced; however, no parts were returned for further investigation.The control inserts were 2337 days old at the time of replacement.The part was 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 component due to the high component age of 2337 days.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 inserts 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: 04dec2018.System installation date: 11jan2019.Unique device identified (udi): (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: 22079203
• Report Number: 3005496266-2025-00006
• Device Sequence Number: 8711500
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)181204
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,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: 04/27/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2018
• 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