MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 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	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: investigation findings appropriate term/code not available: proposed code: loose screws.
Event or Problem Description
It was reported that on (b)(6) 2024, during a selenia dimensions procedure the c-arm was jerking while doing tomo exposures.A field engineer examined the equipment on (b)(6) and it was determined that the screws behind the vta assembly were loose, engineer retightened them and ordered a new kit for repair.The system met the manufacturer´s specifications.No patient injury or staff reported.
Additional Manufacturer Narrative
Selenia dimensions: c-arm jerks during tomo exposures.On 9/19/2024, it was reported that the c-arm was jerking during the tomo motion.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 2,861 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: the complaint review identified that the vta and bolts were original to the system therefore, the dhr was reviewed.No discrepancies related to the vta were found.System product code: sdm-sys-6000-3d.Serial number: (b)(6).Manufacture date: 07-27-2016.System installation date: 12-08-2016.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: 20646017
• Report Number: 1220984-2024-00127
• Device Sequence Number: 7470846
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)160727
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/25/2025

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: 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: 09/19/2024
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/27/2016
• 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