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

Model Number	3DM-SYS-INTLD3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6), that a 3dimensions was moving by itself due to a switch getting stuck.The field engineer examined the device and found that a rotary switch might have mechanical issue.The field engineer replaced the defective switch and tested functionality.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
The 510k for this product is p080003.
Additional Manufacturer Narrative
It was reported that the rotary switch was getting stuck, unintentionally rotating the c-arm.Replacement of the rotary switch was proposed.The field engineer (fe) replaced the switch to resolve the issue.No patient or user injury was reported.A review of this device¿s history showed that the issue did not return after the rotary switch was replaced.The rotary switch was replaced; however, no parts were returned for further investigation.The rotary switch was 349 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 an issue with the rotary switch.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 were no discrepancies related to the rotary switch.System product code: 3dm-sys-intl3d, serial number: (b)(6), system manufacture date: november 14th, 2022, system installation date: on (b)(6) 2023, unique device identified (udi): (b)(4).

• Brand Name: 3DIMENSIONS
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102
• MDR Report Key: 19601192
• Report Number: 1220984-2024-00064
• Device Sequence Number: 6236967
• Product Code: OTE
• UDI-Device Identifier: 15420045510579
• UDI-Public: (01)15420045510579(11)221114
• Combination Product (Y/N): N
• 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,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-INTLD3D
• Device Catalogue Number: 3DM-SYS-INTLD3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; 07/18/2025
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 02/07/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2022
• 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