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

Model Number	3DM-SYS-INTL2D-MOB
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On july 21, 2025, an incident was reported by our customer involving the 3dimensions mammography system.During a patient screening, the operator activated the automatic rotation function of the c-arm, which then rotated beyond the intended 45-degree limit.No error message was displayed at the time.Although the movement was unexpected, no injury occurred to the patient or medical staff.A field service engineer (fse) was dispatched to evaluate the equipment and was unable to replicate the issue.The fse reports there were several errors in the system logs; therefore, the fse completed and unsetup/setup and cleared the system database.The fse checked the c-arm rotation and found no errors.No further information is currently available.
Additional Manufacturer Narrative
An investigation was conducted: it was reported that on (b)(6) 2025 the operator activated the automatic rotation function of the c-arm of a 3dimensions device and the c-arm rotated beyond the intended 45-degree limit.The system was then restarted.A field engineer (fe) examined the equipment and could not reproduce the issue.The fe cleared all errors and checked the rotation of the c-arm with no errors.There were no reported patient or user injuries, and no additional information is available.No parts were replaced or returned for further investigation.A review of this device history showed that the issue did not return after this event.Click or tap here to enter text.As reported, the c-arm rotated beyond the intended 45 degrees.The fe examined the equipment and no issues were found.Click or tap here to enter text.The probable cause of the uncommanded movement is unknown.The fe was unable to replicate the uncommanded movement.Further investigation could not be performed as no part was returned.Due to the limited information provided and lack of part return, the root cause of the uncommanded c-arm movement could not be determined.Conclusion: based on a review of the complaint, a capa (nce, design update, scar) is not needed at this time as there was no patient or user harm.The risk level did not change from what is documented in the dimensions risk file and is considered very low based on the occurrence.The root cause of the uncommanded movement is unknown.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 that c-arm components were original to the system therefore, the dhr was reviewed.There were no discrepancies noted in the dhr.The c-arm was configured on this gantry and passed functional testing with no issues noted.System product code: 3dm-sys-intl2d-mob serial number: (b)(6) event date: 21jul2025 system manufacture date: 20aug2021 system installation date: (b)(6) 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: 22743170
• Report Number: 3005496266-2025-00044
• Device Sequence Number: 8385929
• Product Code: OTE
• UDI-Device Identifier: 15420045510593
• UDI-Public: (01)15420045510593(11)210820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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-INTL2D-MOB
• Device Catalogue Number: 3DM-SYS-INTL2D-MOB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2021
• 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