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

Model Number	SDM-00001-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on october 26th that the c-arm was moving up and down exposures, and was moving on its own.A field engineer examined the equipment and replaced the switches banks and the system met the manufacturer´s specifications.No injury to the patient nor staff.No other information is available.
Additional Manufacturer Narrative
Device history record (dhr) review: system product code: sdm-00001-2d.Serial number: (b)(6).System manufacture date: 3/5/2012.System installation date: 4/19/2012.Unique device identified (udi): (b)(4).A review of the complaint history for (b)(6) showed one additional complaint for uncommanded c arm rotation.On 4/17/2023, the customer reported uncommanded c-arm rotation.The fe was dispatched to the customer site and was unable to recreate the issue.The fe noticed the system flagged with a crm (32:20) error which indicates an issue with the right control insert.The fe replaced both the left and right control insert to resolve the issue (asy-16288).The control inserts were not returned; therefore, no further investigation can be performed.Cause/root cause: the probable cause of the uncommanded movement is due to an issue with the control inserts.Issues that can lead to uncommanded motion include broken slide/rock mounts, worn buttons and broken connectors.Further investigation could not be performed as the part was not returned.Due to the limited information provided and lack of part return, the root cause of the control insert failure could not be determined.Conclusion: complaint not confirmed as there was no returned product for post market quality assurance (pmqa) evaluation.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 very low based on the occurrence.Future events will be monitored and trended.

• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18115301
• Report Number: 1220984-2023-00078
• Device Sequence Number: 7016643
• Product Code: MUE
• UDI-Device Identifier: 15420045505582
• UDI-Public: (01)15420045505582(11)160824
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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-00001-2D
• Device Catalogue Number: SDM-00001-2D
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown