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

Model Number	3DIMENSIONS
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a 3 dimensions procedure on (b)(6) 2025, the customer reported that the vertical position would move on its own, with or without user.A fe examined the equipment and could not duplicate the exact issue.Both footswitches were replaced and the system met the manufacturer´s specifications.No other information available.
Additional Manufacturer Narrative
On march 28th, 2025, a customer observed un-commanded motion on a 3dimensions (serial number (b)(6)).There was no alleged health impact or consequence.The field service engineer (fse) could not duplicate the behavior and replaced both footswitches.The part was scrapped on site.Because of this, there was no part returned, and no initial evaluation performed.The footswitches were 2009 days old from the install date to the date of replacement.Because the part was not available, the investigation is limited to a complaint review.There were no prior footswitch related issues or un-commanded motion issues after the fse performed the troubleshooting.Possible causes for footswitch issues include wear and tear due to part use or debris accumulation due to its location on the floor.The footswitch was not returned; therefore, further investigation could not be performed.Due to the limited information provided and lack of part return, the root cause of the failure could not be determined.Conclusion: the probable cause is a stuck footswitch; the root cause is unknown due to the unreturned part.The severity for this incident is very low, and the calculated post risk control risk index is considered acceptable.Because of this, and because there was no severe injury, no capa is required.This will continue to be trended and monitored.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4).Sku: 3dm-sys-std.Serial number: (b)(6).Date of manufacture: 9/17/2019.Installation date: 9/30/2019.Incident date: 3/28/2025.Closest pm to complaint date: 11/15/2024.Date of part manufacture: unknown.Dhr review summary: no discrepancies were associated with footswitches.

• 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 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21914631
• Report Number: 1220984-2025-00058
• Device Sequence Number: 9390876
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)190917
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/16/2025

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: 3DIMENSIONS
• Device Catalogue Number: 3DIMENSIONS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/17/2019
• 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