MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, during a selenia procedure the c-arm kept moving continuously due to the switches sticking.A field engineer examined the equipment and it was found that the switches needed to be replaced.The switches were replaced and the system tested and met the manufacturer´s specifications.No patient or staff injury reported.
Additional Manufacturer Narrative
Di: (b)(4).
Additional Manufacturer Narrative
Devices were returned for investigation : two control inserts were received (1 right and 1 left).A visual inspection of the returned control inserts confirmed the gantry control button on the left control insert was difficult to move.The right control insert did not show any signs of damage.Further inspection on the left control insert showed that the slide/rock mount was broken thus confirming that the cause of the uncommanded motion and sticking left control insert was the broken slide/rock mount.A risk assessment was performed and the probability of occurrence is very low.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.Device history record (dhr) review: a review of the complaint history for 81002166205 showed no other complaints for uncommanded c arm rotation.Additionally, the complaint review identified the failing control inserts were original to the system therefore, the dhr was reviewed.There were three discrepancies noted in the dhr, however none of the discrepancies were related to the control inserts.The c arm control inserts were tested with no failures/issues noted.System product code: sdm-sys-9000-3d serial number: (b)(6) system manufacture date: 2/17/2016 system installation date: 3/18/2016 unique device identified (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• 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 zone building b24; san jose 20102
• MDR Report Key: 18398098
• Report Number: 1220984-2023-00085
• Device Sequence Number: 2810418
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)160217
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/28/2024

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: SDM-SYS-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2016
• 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