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

Model Number	3DM-SYS-NTL2D-MOB
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the customer reported that during a 3 dimensions prior to the procedure the c-arm moved without any action performed by the user.The footswitch was stuck in the down position.The customer reported a burning smell.No injury to the patient or staff was reported.No patient was at the room at the time.A field engineer examined the equipment and replaced the footswitch which resolved the issue.No other information available.
Additional Manufacturer Narrative
On january 7th, 2025, the customer reported an incident with our 3dimensions mammography system prior to a procedure.It was reported that the c-arm was moving down without any action performed by the user.When the c-arm was moved up, it went all the way down.The foot switch was stuck in the down position.The customer has also reported a burning smell.No injury was reported to the user, and no patient was in the room at the time of the incident.The part was not returned for investigation; therefore, age could not be confirmed.Due to the part not being returned, the investigation will be limited.A complaint trawl will be performed but further investigation into root cause is not possible due the part not being returned.The probable cause is that the footswitch malfunctioned since the unintended behavior was resolved through replacing the footswitch.The root cause is unknown due to the unreturned part.Based on this investigation, the probable cause is that the footswitch malfunctioned in a manner that resulted in the c-arm moving in a downward direction.Root cause is unknown as the part was not returned for investigation.The risk index remains in zone 1, which is considered acceptable risk.A capa is not needed at this time as there was no patient or user harm and because the risk is considered low based on the occurrence rate.Future events will be monitored and trended complaint confirmed: no.Device history record (dhr) review: review of the complaint records for this system indicate the footswitch was previously replaced due to being unresponsive on 04/06/2022.As this is an accessory, a dhr review is not warranted.Serial number: (b)(6).Date of manufacture: 04/09/2019.Date of installation: (b)(6) 2019.Unique device identifier (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 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21305297
• Report Number: 1220984-2025-00008
• Device Sequence Number: 8169154
• Product Code: OTE
• UDI-Device Identifier: 15420045510593
• UDI-Public: (01)15420045510593(11)190409
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 05/21/2025

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-NTL2D-MOB
• Device Catalogue Number: 3DM-SYS-NTL2D-MOB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown