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

Model Number	3DM-SYS-INTL3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on the (b)(6) 2024, our dealer reported an incident with our 3dimensions mammography system.It was reported that the system shut down while using.Dealer also reported that some error codes were displayed.On 10th of october 2024, our hologic technical service reviewed logs and video provided by the dealer.From the logs, it was confirmed that error code vta 29:17 appeared at the time of the incident.This error code vta 29:17 is triggered when an uncommanded vertical motion of the c-arm is detected.From a video, our hologic technical service could confirm that the c-arm slightly moved downwards, potentially due to the brake not engaging.The incident occurred before procedure without patient in the room.No injury was reported to the user/staff.
Additional Manufacturer Narrative
H6 appropriate term/code not available: suggested code: brake.
Additional Manufacturer Narrative
On (b)(6) 2024, our dealer reported an incident with our 3dimensions mammography system.It was reported that the system shut down while using.Dealer also reported that some error codes were displayed.On 10th of october 2024, our hologic technical service reviewed logs and video provided by the dealer.From the logs, it was confirmed that error code vta 29:17 appeared at the time of the incident.This error code vta 29:17 is triggered when an uncommanded vertical motion of the c-arm is detected.From the video, our hologic technical service could confirm that the c-arm slightly moved downwards, potentially due to the brake not engaging.The incident occurred before a procedure without the patient in the room.No injury was reported to the user/staff.On 10th of october 2024 that our hologic field engineer visited the site to examine the system for uncommanded movement of c-arm.Our hologic field engineer found the issue occurred during the height adjustment.The c-arm slightly moves downwards, as the brake did not engage.Our hologic field engineer checked the mechanical parts of the vertical travel assembly (vta) and found that a clutch is defective.The clutch is designed and meant to prevent uncommanded motions of the c-arm.Our hologic field engineer identified the cause of this incident is a defective clutch.The defective clutch has been replaced.After a functional check-up of the system our hologic field service engineer confirmed the system was working according to the specifications.The drag brake was not returned for further investigation.The drag brake was 1817 days old at the time of the complaint.Because no part was returned, the investigation will be limited.A review of the device history showed that the behavior did not recur since this complaint.Conclusion: in summary, while the root cause is unknown, the probable cause is a motor clutch malfunction.The risk index remains in zone 1 which is acceptable risk.A capa is not needed at this time as there was no patient or user harm and because the risk is considered low based on the occurrence.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4).Sku: 3dm-sys-intl3d.Serial number: (b)(6).Date of manufacture: 10/17/2019.Installation date: (b)(6) 2019.Incident date: (b)(6) 2024.Date of part manufacture: n/a ¿ this information is not available as no part was returned.Dhr summary: there were no discrepancies in the dhr related to uncommanded/uncontrolled motion.Complaint record for this system: there were no other complaints related to uncommanded/uncontrolled motion on this system.

• Brand Name: 3DIMENSIONS
• 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: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 20604353
• Report Number: 1220984-2024-00125
• Device Sequence Number: 18120055
• Product Code: OTE
• UDI-Device Identifier: 15420045510579
• UDI-Public: (01)15420045510579(11)191017
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 04/18/2025

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-INTL3D
• Device Catalogue Number: 3DM-SYS-INTL3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2019
• 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