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

Model Number	DIMENSIONS 3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on may 9, during a biopsy procedure, the c-arm rotated on its own.A field engineer examined the equipment and found that the rotation switch at the rear of the gantry was sticking, causing uncommanded motion.The field engineer replaced the rotation handle on the bottom of the c arm.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
It was reported that on (b)(6) 2024, there was uncommanded c-arm motion on a selenia dimensions after the needle was removed during a biopsy procedure.It is reported that the c-arm suddenly rotated on its own toward 180°.A field engineer (fe) examined the equipment and found that the rotation switch at the rear of the gantry was sticking, causing uncommanded motion.The fe manually adjusted the rotary switch to resolve the issue.There were no patient or user injuries reported.A review of this device history showed that the issue did not return after the rotary switch was adjusted.The rotary switch was not replaced; therefore, no parts were returned for further investigation.The rotary switch was 258 days old at the time of adjustment.The part was not returned for further investigation.The probable cause of the uncommanded movement is due to an issue with the rotary switch.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.Future events will be monitored and trended.Complaint confirmed: no 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.The complaint review identified the rotary switch was original to the system therefore, the dhr was reviewed.There were no discrepancies that were related to the rotary switch.System product code: sdm-sys-6000-3d, serial number: (b)(6), system manufacture date: june 30th, 2023, system installation date: (b)(6) 2023, unique device identified (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS 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: 19405193
• Report Number: 1220984-2024-00048
• Device Sequence Number: 15216258
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)230630
• Combination Product (Y/N): N
• 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): 07/01/2025

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: DIMENSIONS 3D
• Device Catalogue Number: SDM-SYS-6000-3D
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown