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	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on january 29, that the selenia dimensions c-arm continues to move after releasing the rotary switch.A field engineer examined the equipment and found that the rotary switch at the back of the c-arm was stuck intermittently.The field engineer replaced the rotary switch and tested it.The equipment met the manufacturer´s specifications.No injury to the patient or staff was reported.No other information is available.
Additional Manufacturer Narrative
An investigation was performed: on (b)(6) 2024, the customer reported that the c-arm was continuing to rotate after the lever was released.The field engineer (fe) was dispatched to the customer site and found the rotary switch (asy-01503) was sticking.The fe replaced the rotary switch to resolve the issue.No patient or user injury was reported.A review of the device history showed this issue did not reoccur after the rotary switch was replaced.The rotary switch was not returned for further investigation.The rotary switch was 584 days old at the time of replacement.Further investigation could not be performed as the part was 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 carried out.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 that the failing rotary switch was 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 (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 20102
• MDR Report Key: 18767811
• Report Number: 1220984-2024-00019
• Device Sequence Number: 12669411
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care 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?: 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/23/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown