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	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a 3dimensions mammography system procedure, the c-arm continued to move past the intended stop position.A field engineer was dispatched to examine the equipment and found that a switch on the c-arm was stuck, which caused the uncommanded c-arm motion.The field engineer cleaned and lubricated the c-arm rotation switch, replaced worn hardware and made adjustments to prevent the rotation switch from rubbing against the frame of the c-arm.The field engineer confirmed that the system is now working in accordance with manufacturer specifications.No patient or user injury reported.
Additional Manufacturer Narrative
It was reported that when moving to mediolateral oblique (mlo) position, the c-arm kept moving past the intended stop position with no patient on the system.The gantry and aws were rebooted.A field engineer (fe) examined the equipment and found that bringing the gantry to mlo position causes the c-arm to continue rotation automatically.The fe reported that the rotation, and automatic motion was due to a stuck rotary switch.The mounting block of the rotary switch was cleaned and lubricated.The rotary switch and worn spacing washer were replaced, and the paddle was adjusted to prevent the rotary switch from rubbing against the frame of c-arm.According to the fe, the rotary switch was no longer sticking.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 replaced.The c-arm rotary switch was replaced; however, no parts were returned for further investigation.The rotary switch was 1142 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 1,142 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: 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 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: march 7, 2022.System installation date: april 27, 2022.Unique device identified (udi): (b)(4).

• Brand Name: 3DIMENSIONS
• 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: 22420444
• Report Number: 3005496266-2025-00025
• Device Sequence Number: 12952185
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)220307
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/05/2025

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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2022
• 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