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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia 3d dimensions procedure, the customer reported that the tomo motion was stuttering, a field engineer examined the equipment and it was determined that screws were loose after the tomo pot failure.The rotational screws were replaced and resolved the issue.The system met the manufacturer´s specifications.No patient or staff injury reported.No other information available.
Additional Manufacturer Narrative
Selenia dimensions: tomo motion is stuttering on (b)(6) 2024, it was reported that the tomo motion was stuttering on the system.The field engineer (fe) was dispatched to the customer site and found the vertical travel assembly (vta) bolts were loose.The fe replaced the vta bolts to resolve the issue.No patient or user injuries were reported.A review of the device history showed this issue has not recurred since the part was replaced.The vta bolts were not returned for investigation.The vta bolts were on the system for 3,044 days.The vta bolts were not returned for further investigation.Conclusion: this investigation will be closed and the root cause investigation for this issue will be documented.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: a review of the complaint history for (b)(6) was performed and no additional complaints related to loose vta bolts were found.The complaint review identified that the vta and bolts were original to the system therefore, the dhr was reviewed.There were no discrepancies related to the vta.System product code: sdm-sys-9000-3d serial number: (b)(6) manufacture date: 08-03-2016 system installation date: 08-11-2016 unique device identifier (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 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: 21112387
• Report Number: 1220984-2025-00005
• Device Sequence Number: 8760182
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)160803
• 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): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SDM-SYS-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2016
• 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