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

Model Number	SDA-SYS-3000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), that the c-arm from the selenia dimension appears to not stop when she releases the foot switch likely a stuck foot switch issue.A field engineer examined the equipment and found that the footswitch button not releasing causing unintended motion, it was removed and replaced footswitches.The system is functioning properly and meets all manufacturer specifications.No injury reported.
Additional Manufacturer Narrative
On (b)(6) 2024, on a selenia dimensions (serial number (b)(6)), the c-arm continued moving when the foot pedal was released by the operator.This occurred during a patient exam, but no health consequences or impact was alleged.The field service engineer (fse) replaced the two footswitches.The symptoms did not recur when tested by the fse.The replaced part was scrapped on site, so no initial evaluation could be performed.Since the foot pedal was scrapped on site, the investigation is limited.Footswitches were requested from the field for comparable sample collection; however, no samples were received that caused uncontrolled motion.Further investigation into root cause is not possible at this time.The fse detailed that debris from outside (¿winter grit¿) was found in the footswitch and prevented the switch from popping up after being depressed.The footswitch is ipx6 rated which certifies the part as water resistant but not dust/particle resistant.Selenia dimensions (serial number (b)(6)) was installed on july 24th, 2023, and the issue was identified on (b)(6) 2024.No further symptoms were observed after the footswitch was replaced on (b)(6) 2024 through routine troubleshooting.Based on input from the fse, the probable cause was outside material accumulating inside the pedal.Conclusion: in summary, the probable cause was outside material accumulating inside the pedal.A capa is not required for this incident as there was no alleged impact to patient or user and because the risk level did not change.This behavior will continue to be monitored and trended.Complaint confirmed: no device history record (dhr) review: system serial number: (b)(6), system date of manufacture: 6/26/2023, gantry sku: asy-04160, gantry serial number: (b)(6), gantry date of manufacture: 6/6/2023, gantry udi: (b)(4), installation date: 7/24/2023, date of complaint: 2/21/2024.There were no other complaints related to uncontrolled/uncommanded motion for this system since this incident.Reviewed the dhr: no deviations listed were related to this behavior.

• 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, MA 20102
• MDR Report Key: 18866845
• Report Number: 1220984-2024-00022
• Device Sequence Number: 3325660
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: (01)15420045505636(11)230606
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P010025
• 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): 06/16/2025

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: SDA-SYS-3000-3D
• Device Catalogue Number: SDA-SYS-3000-3D
• 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: 02/21/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2023
• 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