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

Model Number	3DM-SYS-STD
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that on (b)(6) 2026, during use of a 3dimensions mammography system, an unusual noise was heard during the tomosynthesis sweep.It was reported that the event occurred during a patient exam.The caller reporting the issue was not the technologist operating the system and was unable to provide further details regarding the nature of the noise.No user or patient injuries were reported.A hologic field service engineer (fse) was dispatched to investigate the device and observed abnormal noise and vibration during tomosynthesis motion.Upon inspection, the fse found that two c-arm rotation bolts within the vertical travel assembly (vta) were broken.The fse removed and replaced the vta assembly and associated components and reassembled the system.Required calibrations and quality control testing were performed.Following the repair, the tomosynthesis motion was verified and the system was confirmed to be operating according to manufacturer specifications.No further information is currently available.

• 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: ugo chibueze ; 445 simarano drive; marlborough, MA 01752
• MDR Report Key: 25131558
• Report Number: 3005496266-2026-00094
• Device Sequence Number: 10347062
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)221026
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/26/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 05/09/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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