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	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 5th of august 2024, customer reported an incident with our selenia dimensions mammography system.It was reported that the c-arm started moving vertically without any command from the user.It was also reported that vta 29:17 error was shown on the system.The incident occurred prior to procedure with no patient in the room.No injury was reported to the user/staff.A field engineer visited the site to examine the system.Vta 29:17 error usually appears when the system detects a c-arm¿s vertical motion issue.Our hologic field engineer observed that when releasing the switch to move the c-arm down, the c-arm did not stop right away (did not stop as fast as expected).The movement of the c-arm continued to approximatively 0,5cm without command, triggering the vta 29:17 error.Our hologic field engineer checked the mechanical parts of the vertical travel assembly (vta) and found that a clutch is defective.The clutch part number asy-03665 is designed and meant to prevent uncommanded motions of the c-arm.Our hologic field engineer confirmed the root cause of this incident is a defective clutch.The defective clutch asy-03665 has been replaced.The system was extensively tested and is now operating according to specifications.
Additional Manufacturer Narrative
On (b)(6) 2024, our customer reported an incident with our selenia dimensions mammography system with serial number (b)(6).It was reported that the c-arm started moving vertically without any command from the user.It was also reported that a vta error was shown on the system.The incident occurred prior to procedure with no patient in the room.No injury was reported to the user/staff.On the (b)(6) 2024, our hologic field engineer visited the site to examine the system.Vta error usually appears when the system detects a c-arm¿s vertical motion issue.Our hologic field engineer observed that when releasing the switch to move the c-arm down, the c-arm did not stop right away (did not stop as fast as expected).The movement of the c-arm continued to approximately 0.5cm without command, triggering the vta error.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 confirmed the cause of this incident is a defective clutch.The defective clutch has been replaced.The system was extensively tested and is now operating according to specifications.The drag brake was not returned for further investigation ¿ it was scrapped on site.The drag brake was 2309 days old from the date of system manufacture to the date of the incident.Because no part was returned, the investigation will be limited.Reviewing the error codes, vta 29:17 is the originating error code which indicates unexpected vertical motion in the downward direction or stalling.This then triggers an emergency gantry shutdown as a safety feature.A review of device history showed that this behavior did not recur since the troubleshooting performed by the fe.Due to the unreturned part, the root cause of the uncontrolled motion is unknown.The probable cause is a malfunctioning drag brake due to wear and tear.Conclusion: in summary, while the root cause is unknown, the probable cause is a motor clutch malfunction.The risk index remains in zone 1 with an ri of 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: sdm-sys-6000-3d, serial number: (b)(6), date of manufacture: 4/10/2018, installation date: (b)(6) 2018, incident date:(b)(6) 2024, date of part manufacture: unknown.Dhr review: there were no discrepancies in the dhr related to this behavior.Selenia dimensions final test record, right c-arm switch functions & left c-arm switch functions tested upward and downward.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• 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: 20113113
• Report Number: 1220984-2024-00095
• Device Sequence Number: 12600051
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)180410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/30/2024

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: Not provided
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2018
• 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