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	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia procedure on (b)(6) 2024, the c-arm keeps rotating upside down when auto rotation is selected, the c-arm is not stopping at the detent position.The equipment was examined by a field engineer and replaced the c-arm transition and control board ant the system met the manufacturer´s specifications.No patient or staff injury reported.No other information available.
Additional Manufacturer Narrative
Investigation was concluded: the customer reported that the system would rotate upside down when the auto-rotation was selected.The field engineer (fe) was dispatched to the customer site and replaced the c-arm board and c-arm transition board to resolve the issue.No patient or user injury was reported.A review of the device history showed this issue did not recur after the boards were replaced.The parts were not returned for further investigation.Further investigation could not be performed as the parts were not returned.Based on a review of the complaint, the likely cause of the uncommanded movement is due to an issue with either the c-arm board or c-arm transition board.A possible cause of the issue could be related to natural wear and tear due to high part age.The pcbs were not returned therefore further investigation could not be performed.Due to the limited information provided and lack of part return, the root cause of the failure could not be determined.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 was calculated and is considered very low based on the occurrence.Future events will be monitored and trended.The complaint review identified the c-arm board and c-arm transition board were original to the system therefore a dhr review is required.There were no discrepancies noted in the dhr.The c-arm transition board was installed with no issues noted.The c-arm board was installed with no issues noted.System product code: sdm-sys-6000-3d.Serial number: (b)(6).System manufacture date: 9/18/2017.System installation date: 10/3/2017.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: 18731251
• Report Number: 1220984-2024-00017
• Device Sequence Number: 14849689
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)170918
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/23/2025

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: 02/05/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2017
• 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