MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D

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	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on april 16, during a procedure the c-arm moved intermittently when the system was in lateral position when the tube head was on the left side.A field engineer examined the equipment and was unable to reproduce the failure mode.The field engineer replaced the vertical drag brake and confirmed that the backlash measurements on the main gear were passing.The system is functioning properly and meets all manufacturer specifications.No injury was reported.
Additional Manufacturer Narrative
Investigation was concluded: on (b)(6) 2024, on a selenia dimensions (serial number (b)(6), a customer reported uncommanded c-arm motion.When in a lateral position with the tube head on the left (-90 degrees medial lateral angle) during a patient exam/procedure, the c-arm lowered vertically near the end of a tomo sweep.There was no alleged customer/patient health consequence or impact.The customer¿s biomedical engineer could not duplicate the issue but replaced the vertical drag brake and confirmed the backlash measurements were passing.No part was returned, so an initial evaluation is not able to be performed.Because no part was returned and because this system was serviced by the customer¿s biomedical engineer (not a hologic field service engineer), the investigation will be limited.The root cause is unknown; however, based on this limited information, the probable cause was a vertical drag brake malfunction.The lot number was not available.Conclusion: in summary, while the root cause is unknown, the probable cause is a motor clutch malfunction.The risk index remains in zone 1 with an ri of 2.This is acceptable risk per procedures.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.Future events will be monitored and trended.Device history record (dhr) review: udi: (b)(4), sku: sdm-sys-6000-2d, serial number: (b)(6), date of manufacture: 12/6/2017, installation date: 12/22/2017, complaint date: 4/16/2024.Date of part manufacture: unknown ¿ the part was not returned, and no lot information was provided.Dhr review: no related discrepancies or deviations found.Device was released per manufactuer´s specifications.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D
• 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: 19305793
• Report Number: 1220984-2024-00046
• Device Sequence Number: 7333453
• Product Code: MUE
• UDI-Device Identifier: 15420045510753
• UDI-Public: (01)15420045510753(11)171206
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: SDM-SYS-6000-2D
• Device Catalogue Number: SDM-SYS-6000-2D
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2017
• 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