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	Bruise/Contusion (1754)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that during a 3dimensions mammography system procedure on (b)(6) 2026, the "c-arm moved from 35 degrees to 180 degrees with no user input."[the]" patient in "[a]" wheelchair sustained a bruised arm." additional information was received from the customer regarding the patient's status, in which it was reported "the patient received a light bruise on her arm and leg.The patient declined medical attention, and no further action was taken by the staff." a hologic field service engineer was dispatched to assess the device and determined "after checking the logs it was found that the left c-arm switch was responsible for the movement that occurred.Some debris buildup was also found underneath the rotational switch." the fse replaced both c-arm switch banks, inspected, tested and calibrated the unit in accordance with manufacturer specifications.No further information is currently available.

• Brand Name: 3DIMENSIONS
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 600 technology dr; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC.; 600 technology dr; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology dr; newark, DE
• MDR Report Key: 25883513
• Report Number: 3005496266-2026-00194
• Device Sequence Number: 10124491
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)190820
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/27/2026

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: 06/22/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2019
• 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