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	Bone Fracture(s) (1870)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a selenia dimensions patient procedure on (b)(6), 2025, the unit lowered itself without command.The customer reports that while positioning the patient who was reported to be in a wheelchair, the unit lowered, and it broke the patient's ankle.The customer denies observing any error codes on the system at the time of the reported event.No further information regarding the patient status is available.A hologic field service engineer (fse) was dispatched to examine the system.The fse tested all of the switches on both foot pedals, including the c-arm down switch and was unable to find any to be faulty.Additionally, the fse checked the vertical drag brake, which is installed on the system and found it to be working as intended.The fse also completed several c-arm up/down cycles with no issues.The fse in conjunction with hologic technical support remoted into the system to review the log files around the reported time of the incident and again, no issues were found.Testing of the device and review of system logs found no issues with the device, and it is reported to be functioning in accordance with manufacturer specifications.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on (b)(6) 2025 around 2:08pm after an exposure, a patient on a wheelchair was being positioned from behind when the c-arm moved downward about 2 to 3 inches, striking the patient¿s leg.The customer was unsure if their foot was on the c-arm down switch on the foot peddle or not.The patient was found to have a broken ankle.No system errors were observed.A field engineer (fe) examined the equipment and tested all the footswitches on both pedals.No issues were noted.The vertical travel assembly (vta) backlash was examined, and no issues were noted.The vertical drag brake installed on the system and was working as intended.The fe moved the c-arm up and down several times and no issues were observed.The fe concluded all brakes and switches were operating as intended.A review of this device history showed that the issue did not return after this incident.No parts were replaced; therefore, no parts were returned for further investigation.Log files from (b)(6) 2025 that captured from 1:45pm to 2:30 pm were reviewed and indicated that an exposure took place and ended at 14:08:30.Shortly afterward, the footswitch (pmc) was activated for c-arm down from 14:09:49 to 14:09:53.The system registered compression readout was 15.9 cm at approximately 0lbs of force when the c-arm down was activated.The compression force remained at zero throughout.At 14:10:20, the c-arm up was activated via footswitch until 14:10:25.According to log files that the patient was not under compression at the time of the event.Further evaluation of the log files revealed that the source identity (sid) of the downward movement at 07:47:49 to 07:47:55 was initiated by the footswitch.The footswitch command was represented by the power module control (pmc), which gives the footswitch status.The destination identity (did) was the gantry control board (gcb), where the c-arm movement is controlled.There were no system errors or faults.No parts were returned for further investigation.The probable cause of the uncommanded movement is due to user error.The log files indicated that the footswitch pedal was pressed to move the c-arm down while there was no recorded patient compression.In the dimension systems, the c-arm will move when commanded if the compression force is at or below the motion lockout force of 5lbs.Vertical movement and rotation of the c-arm are restricted when compression force is applied.The compression force displays 0.0 lbs when the force is less than 4 pounds; however, the logs showed no force detected by the strain gauge.Motion is permitted with or without compression when the force is at or below 5lbs.In this case, the force was 0.0 lbs during the downward movement of the c-arm, therefore c-arm movement occurred when the foot switch was pressed.There was no detected compression force until after the c-arm was moved back up.The 3dimensions user guide cautions that the footswitch should be positioned to prevent accidental activation by the patient or interference from a wheelchair.To reinforce this guidance, the footswitch features a prominently displayed wheelchair caution symbol at its center.The gantry switches, control inserts, and footswitches are all the control components for vertical c-arm movement and were tested by the field service engineer (fse) with no issues identified.The likely cause is due to an inadvertent activation by the user of the c-arm via the footswitch.Further investigation could not be performed as the part was not returned.Conclusion: based on a review of the complaint, a capa is not needed at this time.Although patient harm was reported, the risk is considered acceptable based on the risk index.The likely cause is user error of pressing the footswitch inadvertently, moving the c-arm.The 3dimensions user guide cautions that the footswitch should be positioned to prevent accidental activation by the patient or interference from a wheelchair.To reinforce this guidance, the footswitch features a prominently displayed wheelchair caution symbol at its center.An enhancement was submitted to mitigate the likelihood of potential user error.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.The complaint review identified the c-arm was original to the system therefore, the dhr was reviewed.There were no discrepancies noted in the dhr.The c-arm was configured on the gantry with no issues noted.System product code: sdm-sys-6000-3d serial number: (b)(6) system manufacture date: february 27th, 2019 system installation date: (b)(6) 2019 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: 23133794
• Report Number: 3005496266-2025-00059
• Device Sequence Number: 9285311
• Product Code: OTE
• 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): 09/24/2025

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown