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

Model Number	SDM-SYS-6000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6), during a selenia dimensions procedure an uncommanded c-arm motion was observed.No patient nor staff injury reported.A field engineer examined the equipment and determined that the c-arm rotation rocker switch was defective.The c-arm rotation rocker switch was replaced and the system passed all tests and meets the manufacturers specifications.No other information available.
Additional Manufacturer Narrative
D.4: unique device identifier (udi): (b)(4).System product code: sdm-sys-6000-3d.Serial number: (b)(6).System manufacture date: 12/13/2017.System installation date: 12/28/2017.A device history record review is not required as a review of the complaint history for (b)(6) showed the rotary switch was replaced 1055 days prior.The customer reported that the lever to rotate the c-arm was not working therefore, the field engineer replaced the rotary switch and confirmed the system was performing as intended.Rotary switch investigation: the returned rotary switch was 1055 days old prior to replacement.A visual inspection of the rotary switch indicated no visual abnormalities.The returned rotary switch was installed on a working gantry (serial number: (b)(6)).The switch was able to rotate the c-arm without any issues and did not show any signs of sticking.However, the switch turning motion was rough when compared to a new switch.The rotary switch was disassembled, and no issues were noted with the internal components.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, 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 park zone b24; san jose 20102
• MDR Report Key: 19601226
• Report Number: 1220984-2024-00063
• Device Sequence Number: 12332795
• Product Code: OTE
• UDI-Device Identifier: 15420045510760
• UDI-Public: (01)15420045510760(11)171213
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/06/2024

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-6000-3D
• Device Catalogue Number: SDM-SYS-6000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2017
• 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