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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions procedure on (b)(6) 2024, the system was shaking.A field engineer examined the equipment and found that 3 out of the 8 bolts related to the vta assembly had sheared off and broke off.The system was shutdown and the pieces were replaced.The vta gantry's vertical travel assembly was replaced.After replacement the system passed tests and met the manufacturers specifications.No patient or staff injury reported.The system met the manufacturer´s specifications.
Additional Manufacturer Narrative
An investigation was performed.The customer reported the system is shaking during tomosynthesis.The field engineer (fe) was dispatched to the customer site and noticed the vta screws were loose and that 3 out of the 8 screws had sheared off.The fe replaced the vertical travel assembly resolving the issue.No patient or user injuries were reported.A review of the device history showed this issue has not recurred since the vta was replaced.The vta was not returned for investigation.The cause of the system shaking was due to the loose and broken vta bolts.A capa has been opened to investigate the root cause of the loose/broken vta bolts.Conclusion: this investigation will be closed and the root cause investigation for this issue will be documented in a capa future events will be monitored and trended.Device history record (dhr) review: a review of the complaint history for (b)(6) was performed and no additional complaints were found related to system shaking.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-9000-3d, serial number: (b)(6), system manufacture date: 6/19/2017, system installation date: 6/30/2017, unique device identified (udi): (b)(4).
Event or Problem Description
Investigaiton results pending.

• 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; san jose 20102
• MDR Report Key: 19202483
• Report Number: 1220984-2024-00038
• Device Sequence Number: 12788904
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)170619
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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-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: Not provided
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2017
• 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