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

Model Number	3DM-SYS-STD
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on april 2nd, 2025 that the rotary switch on a 3dimensions mammography system was sticking causing uncommanded system motion.A field engineer examined the system and determined that the lower rotary switch needed to be replaced.The field engineer completed the replacement of the rotary switch and confirmed that the system is functioning in accordance with manufacturer specifications.No patient or user injury was reported.
Additional Manufacturer Narrative
It was reported that the rotary switch was sticking, causing uncommanded c-arm movement.A field engineer examined the equipment and replaced the rotary switch to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of the device history showed that uncommanded c-arm movement occurred on (b)(6) 2025 under a separate complaint, where the control inserts were replaced.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 1739 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 natural wear and tear on the component from high component age of 1739 days.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: the complaint review identified the rotary switch was original to the system therefore, the dhr was reviewed.There was no discrepancy related to the rotary switch.The rotary switch was installed on this gantry with no issues noted.System product code: 3dm-sys-std.Serial number: (b)(6).System manufacture date: june 29th, 2020.System installation date: (b)(6) 2020.Unique device identified (udi): (b)(4).

• Brand Name: 3DIMENSIONS
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 21894671
• Report Number: 1220984-2025-00055
• Device Sequence Number: 11623577
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)200629
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/29/2025

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: 3DM-SYS-STD
• Device Catalogue Number: 3DM-SYS-STD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2020
• 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