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	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions procedure the c-arm continued to rotated after the button had been released.A field engineer examined the equipment and determined that the c-arm button was sticking for which it was replaced and the symptoms disappeared.The system met the manufacturer´s specifications.
Additional Manufacturer Narrative
An investigation was performed: on (b)(6) 2024, the customer reported that the c-arm was continuing to rotate after the switch was released.The field engineer (fe) was dispatched to the customer site and found the c-arm rotation button was sticking.The fe replaced the control insert switches to resolve the issue.No patient or user injury was reported.The fe returned to the customer site and found the rotary switch was sticking.The fe replaced the rotary switch to resolve the issue.The control insert switches and rotary switch were not returned for further investigation.The control inserts were 2,039 days old at the time of replacement and the rotary switch was 584 days old.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 the rotary switch.Likely causes for uncommanded motion can include wear and tear to the rotary switch.The rotary switch was 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.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: the complaint review identified the failing control and rotary switches 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: 10/10/2016 system installation date: (b)(6)2016 unique device identified(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: 18705970
• Report Number: 1220984-2024-00014
• Device Sequence Number: 6275957
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)161010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/20/2025

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?: No
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2016
• 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