MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number	SDM-SYS-6000-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a selenia dimensions procedure the automatic angle buttons on both side are intermittently acting up and the intermittent c-arm keeps moving down after the foot is removed from the footswitch.No patient injury or staff injury reported.Equipment is pending to be examined by the field engineer.
Event or Problem Description
Pending results of investigation.
Additional Manufacturer Narrative
Investigation completed: selenia dimensions: c-arm uncommanded motion and control inserts working intermittently.It was reported that the c-arm control inserts were working intermittently.Additionally, the c-arm continued to move after the technician¿s foot was lifted from the footswitch.The field engineer (fe) was dispatched to the customer site and replaced the control inserts resolving the issue.The fe was unable to find any issues with the footswitch and was unable to confirm the uncommanded motion.No patient injuries were reported.A review of the device history showed this issue has not reoccurred since the parts were replaced.The control inserts were 692 days old at replacements and were not returned for investigation.Based on a review of the complaint, a possible cause of the uncommanded movement is due to an issue with the control inserts.Issues that can lead to uncommanded motion include worn buttons/components, broken connectors and broken slide/rock mounts.Natural wear and tear due to part age could not be ruled out as a contributing factor.The control inserts were 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.A risk trend was performed and the occurrence calculation was calculated at 2(low).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 low based on the occurrence.Future events will be monitored and trended.A review of the complaint history for (b)(6) showed no other complaints for uncommanded c arm motion or control switch issues.Additionally, the complaint review identified the failing control inserts were original to the system therefore, the dhr was reviewed.There were two discrepancies noted in the dhr however none of the discrepancies were related to the control inserts.The dimensions footswitches are not contained within the dimensions dhr therefore, no dhr review could be performed.System product code: sdm-sys-6000-2d; serial number: (b)(6); system manufacture date: 1/13/2022.System installation date: 3/10/2022.Unique device identified (udi): (b)(4).

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D
• Common Device Name: FULL FIELD DIGITAL 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; san jose 20102
• MDR Report Key: 18712815
• Report Number: 1220984-2024-00015
• Device Sequence Number: 7056176
• Product Code: MUE
• UDI-Device Identifier: 15420045510753
• UDI-Public: (01)15420045510753(11)220113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010025
• 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,Followup
• Report Date (Section B): 11/01/2024

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-6000-2D
• Device Catalogue Number: SDM-SYS-6000-2D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 01/19/2024; Not provided
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 02/29/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2022
• 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