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	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on july 11th that during a selenia dimensions procedure the c-arm was vibrating and makin and odd noise during tomo sweep.A field engineer examined the equipment and applied lubrication to tomo roller and performed vta work gear adjustment.Performed tomo calibrations.Vta screws were retightened.A scheduled maintenance was programed in august in which its intended to replaced the screws per fmi kit.System was operating according to manufacturer´s specifications and no patient injury or staff was reported.
Additional Manufacturer Narrative
Selenia dimensions: c-arm is vibrating during tomo sweep.On (b)(6) 2024, it was reported that the unit was making noise and vibrating during the tomo sweep.The field engineer (fe) was dispatched to the customer site and found the vta bolts were loose.The fe tightened the bolts and indicated the bolts would be replaced during the next preventative maintenance visit.No patient or user injuries were reported.The vta bolts were not replaced, therefore they were not returned for investigation.The vta bolts were on the system for 2,498 days.The vta bolts were not replaced.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.There were no discrepancies noted in the dhr.System product code: sdm-sys-6000-3d, serial number: (b)(6), system manufacture date: 08-22-2017, system installation date: 09-08-2017, 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: 20140405
• Report Number: 1220984-2024-00100
• Device Sequence Number: 7417083
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)170822
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2017
• 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