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	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text: device evaluation anticipated, but not yet begun.
Event or Problem Description
It was reported on (b)(6) 2025, that the right panel c-arm "up and down" button is sticking on a 3dimensions mammography system.The user reports that when attempting to move the c-arm up and down, it rotates instead.It is reported that this occurred prior to a patient examine and no patient or user injury was reported.A hologic field service engineer (fse) reports that the customer site has requested to have this issue addressed at the next preventative maintenance (pm).No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on (b)(6) 2025, the c-arm up and down button on the right control insert of the c-arm was sticking and at times when attempting to move the c-arm up or down, the arm rotated instead.A field service engineer (fse) examined the equipment and 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 control inserts were replaced; however, no parts were returned for further investigation.The control inserts were 182 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 insert.As reported, the right control insert up, and down button was sticking.The likely cause is related to natural wear and tear on the component.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.The root cause was unable to be determined as no parts were returned.The likely cause is related to natural wear and tear on the control inserts.The risk level did not change from what was previously documented and is considered very low based on the occurrence.Future events will be monitored and trended.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 four discrepancies noted in the dhr, however none of the discrepancies were related to the control inserts.The control inserts were configured on this gantry with no issues noted.System product code: 3dm-sys-std serial number: (b)(6) event date: 27aug2025 system manufacture date: 27feb2025 system installation date: (b)(6) 2025 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: 23134189
• Report Number: 3005496266-2025-00060
• Device Sequence Number: 9917097
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)250227
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/18/2025

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: 08/27/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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