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

Model Number	SDM-SYS-6000-3D
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on july 24, a selenia dimension had a jerky tomo motion and noise.A field engineer examined the device and found that the vta bolts needed to be replaced.The field engineer tightened the worm gear and vta bolts.Performed tomo motion calibrations and tested functionality.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
Selenia dimensions: jerky tomo motion.On 07/24/2024, it was reported that the tomo motion was jerky and noisy.The field engineer (fe) was dispatched to the customer site and tightened the vta bolts.The fe indicated the bolts would be replaced.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 2,511 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 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 20162543
• Report Number: 1220984-2024-00103
• Device Sequence Number: 7312917
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care 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?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 09/06/2024
• 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