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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Headache (1880)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions mammography system procedure, on (b)(6) 2025, the tube spun around to the 170-degree position on its own and hit the technician on the head.It is reported that the technician complained of a "slight headache" on the day of the event but did not need medical attention.It is reported that the customer site manager followed up with the technician the next day and the technician "was good." a field service engineer (fse) was dispatched to assess the equipment and found the rotational switch behind the detector was stuck in the engaged position.The fse replaced the rotational switch, verified that the repair corrected the issue and confirmed that the system meets manufacturer specifications.No patient injury was reported.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a selenia dimensions mammography system procedure, on (b)(6) 2025, the tube spun around to the 170-degree position on its own and hit the technician on the head.It was reported that the technician complained of a slight headache.A field service engineer (fse) examined the equipment and found the rotational switch behind the detector was stuck in the engaged position.The fse replaced the rotational switch to resolve the issue.No patient injury was reported.A review of this device history showed that the issue did not return after the rotary switch was replaced.The c-arm rotary switch was replaced; however, no parts were returned for further investigation.The rotary switch was 3,323 days old at the time of replacement.The part was not returned for further investigation.The probable cause of the uncommanded movement is due to an issue with the rotary switch.The likely cause is related to natural wear and tear on the component due to the high component age of 3,323 days.Another likely cause is due to insufficient spacing of the rotary switch.This can lead to inadequate spacing between the switch and c-arm casting or sticking when the rotary switch is engaged.Further investigation could not be performed as the part was not returned.Due to the limited information provided and lack of part return, the root cause of the rotary switch 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.The likely cause of the rotary switch failure was determined to be due to natural wear on the component or inadequate adjustment of the rotary switch.An nce was opened to address the inadequate spacing.Future events will be monitored and trended.Device history record (dhr) review: a review of the complaint history for (b)(6) showed no additional complaints for uncommanded c-arm movement related to the rotary switch.Uncommanded c-arm movement occurred on (b)(6) 2021, under a separate case.The control inserts were stuck and got replaced to resolve the issue; thus, the event reported in the previous separate case reported on (b)(6) 2021 is unrelated to the event reported on (b)(6) 2025.The complaint review identified the rotary switch was original to the system therefore, the dhr was reviewed.There were eight discrepancies noted in the dhr, however, none of the discrepancies were related to the rotary switch.The rotary switch was installed on this gantry with no issues noted.System product code: sdm-sys-9000-3d, serial number: (b)(6), system manufacture date: 14jun2016, system installation date: 16jun2016, unique device identified (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 22742980
• Report Number: 3005496266-2025-00043
• Device Sequence Number: 8419216
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)160614
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2016
• 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