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

Model Number	3DM-SYS-INTL2D-MOB
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), during a procedure the c-arm had an uncommanded movement.A field engineer examined the equipment and found the c-arm rotation switch behind the detector was sticking.The field engineer replaced the c-arm rotation switch, tested all c-arm switches and the system met the manufacturer´s specifications.No other information is available.No patient or user injury reported.
Additional Manufacturer Narrative
3dimensions: uncommanded c-arm rotation: on 4/8/2024, the customer reported uncommanded rotational c-arm movement.The c-arm turned almost upside down intermittently (stopped and moved again).No patient or user injury was reported.The field engineer (fe) was dispatched to the site and found the rotary switch was sticking.The fe replaced the rotary switch to resolve the issue.A review of the device history showed this issue did not recur after the rotary switch was replaced.Initial evaluation: (b)(4).The rotary switch was not returned for further investigation.Investigation methods and findings: the part was not returned; therefore, further investigation cannot be completed.Cause/root cause: the probable cause of the uncommanded movement is due to the rotary switch sticking.Due to the limited information provided and lack of part return, the root cause of the rotary switch failure could not be determined.Conclusion: this investigation will be closed, and no further investigation is required.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 motion due to the rotary switch.The complaint review identified the rotary switch is original to the system therefore, the dhr was reviewed.There were six discrepancies noted in the dhr however none were not related to the rotary switch.The rotary switch was installed with no failures/issues noted.System product code: 3dm-sys-intl2d-mob.Serial number: (b)(6).System manufacture date: 3/2/2021.System installation date: (b)(6) 2022.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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 19209486
• Report Number: 1220984-2024-00040
• Device Sequence Number: 7927196
• Product Code: OTE
• UDI-Device Identifier: 15420045510593
• UDI-Public: (01)15420045510593(11)210302
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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-INTL2D-MOB
• Device Catalogue Number: 3DM-SYS-INTL2D-MOB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown