MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 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	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia procedure on (b)(6) 2024, the tube kept rotating all the way around and did not stop at 0 degrees.No patient or staff injury reported.A field engineer examined the equipment and determined that the switches were defective.Left and right switches were replaced and the system passed all tests and meets the manufacturer´s specification's.No other information available.
Additional Manufacturer Narrative
It was reported that the c-arm rotated 180 degrees.The auto center button did not allow the c-arm to stop at 0 degrees center.This uncommanded c-arm movement was intermittent.A field engineer examined the equipment and replaced the c-arm control inserts to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of this device history showed that uncommanded c-arm movement occurred on (b)(6) 2024, in which the rotary switch was replaced to resolve the issue.This event occurred after the complaint for this investigation on april 29th, 2024.The issue of uncommanded c-arm movement did not return after the rotary switch was replaced.The control inserts were received from the field for further investigation.The returned control inserts were installed on a working gantry and were 1293 days old at the time of replacement.A visual inspection of the control inserts revealed no abnormalities of the control inserts.Further inspection of the right control insert revealed the slide/rocker frame was dusty.The c-arm control inserts had steady movement and all components were intact.After installing both control inserts on the test gantry, all c-arm commands were initiated.All buttons and switches on both control inserts were tested.The c-arm moved when commanded with no issues.The uncommanded movement could not be replicated.The cause of the uncommanded c-arm motion could not be determined.The issue was not replicated.Log files were not available for review.The likely cause is related to natural wear and tear on the component due to the high component age of 1293 days.Conclusion: based on a review of the complaint, a capa is not needed at this time as there was no patient or user harm.Additionally, the risk is considered very low based on the occurrence.Future events will be monitored and trended.Complaint confirmed: no device history record (dhr) review: a review of the complaint history for (b)(6) showed that the control inserts were replaced on (b)(6) 2020, due to the switches not working.Uncommanded c-arm movement was not reported in the case summary.Uncommanded c-arm movement occurred on (b)(6) 2024, in which the rotary switch was replaced to resolve the issue.This event occurred after the complaint for this investigation on april 29th, 2024.Subsequently, there were no additional complaints for uncommanded c-arm movement related to the control inserts or rotary switch the complaint review identified the control inserts were not original to the system therefore, the dhr was not reviewed.System product code: sdm-sys-6000-3d, serial number: (b)(6), system manufacture date: december 13th, 2017, system installation date: december 28th, 2017, unique device identified (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: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102
• MDR Report Key: 19310657
• Report Number: 1220984-2024-00047
• Device Sequence Number: 16919715
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)171213
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/12/2025

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: 04/29/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2017
• 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