MAUDE Adverse Event Report: HOLOGIC, INC 3DIMENSIONS; MAMMOGRAPHY SYSTEM

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure on february 4th , the system gave a data error at 180 degrees during tomo calibration.A field engineer examined the equipment and found a broken screw broken on the rotation gear related to the vta assembly.All the screws on the rotation gear were replaced and a tomo calibration was performed, the system met the manufacturer´s specifications.No patient injury nor staff reported.
Additional Manufacturer Narrative
Initial evaluation : the broken vta bolt was on the system for 2,329 days.The bolts were not returned by the fe for further investigation.The vta assembly was on the system for 2,381 days prior to replacement.The vta was not returned by the fe for further investigation.The cause of the c-arm shaking and error during calibration was due to a broken vta bolt.A capa has been opened to investigate the root cause of the loose/broken vta bolts.The complaint review identified that the vta and bolts 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 vta assembly.The vta motion calibration was performed with no errors noted.System product code: sdm-sys-9000-3d.Serial number: (b)(6).System manufacture date: 9/13/2017.System installation date: on (b)(6) 2017.Unique device identified (udi): (b)(4).

• Brand Name: 3DIMENSIONS
• 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: 18946402
• Report Number: 1220984-2024-00027
• Device Sequence Number: 17913387
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)170913
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/09/2024

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-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2017
• 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