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	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, that during a 3 dimensions mammography system qc, the c-arm did not stop at the intended stop position of 180 degrees.A field service engineer (fse) was dispatched to assess the unit and found the c-arm stuck in a +190-degree position and was unable to rotate it back.The fse manually rotated the c-arm back to the zero-degree position, calibrated the c-arm zero position and tomo motion, and confirmed that the system is now functioning in accordance with manufacturer specifications.No patient/user injury reported.
Additional Manufacturer Narrative
It was reported that the c-arm continued rotating past 180 degrees.A field engineer (fe) examined the equipment and found that the c-arm was stuck +190 degrees and was unable to rotate back, causing a vta error.The fe manually rotated the c-arm back to zero degrees and calibrated for c-arm zero position and tomo motion to resolve the issue.There were no reported patient or user injuries, and no additional information is available.A review of this device history showed that the issue did not return after the c-arm was manually adjusted.The c-arm was not replaced; therefore, no parts were returned for further investigation.The c-arm was 1625 days old at the time of adjustment.The part was not returned for further investigation.The probable cause of the uncommanded movement is due to an issue with the c-arm.The likely cause is related to zero-degree position and/or tomo motion drift that was resolved with recalibrating each.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 c-arm 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.The complaint review identified the c-arm was original to the system therefore, the dhr was reviewed.There were no discrepancies noted in the dhr.The c-arm was installed on this gantry with no issues noted.System product code: 3dm-sys-std.Serial number: (b)(6).System manufacture date: january 14th, 2021.System installation date: march 3rd, 2021.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: 22535005
• Report Number: 3005496266-2025-00033
• Device Sequence Number: 7488066
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)210114
• 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): 08/18/2025

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: 06/26/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2021
• 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