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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a preventive maintenance for a selenia dimensions 2d on (b)(6) 2023, a broken bolt from the vta assembly was found.The field engineer replaced the vta assembly per procedures and the service manual and performed all required calibrations.All calibrations and tests passed and the system met the manufacturer´s specifications.No patient injury or staff reported.No other information is available.

• 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
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 16674158
• Report Number: 1220984-2023-00034
• Device Sequence Number: 20170185
• Product Code: MUE
• UDI-Device Identifier: 15420045510753
• UDI-Public: (01)15420045510753(11)170310
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 04/04/2023

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: 03/10/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown