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

Model Number	SDM-00001-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the selenia dimensions c-arm was moving on its own.A field engineer examined the equipment and found that the tubehead continued to move trying to find tomo zero home.Adjustments were made to the vta backlash hardware and a rotational drag brake was installed.The system met the manufacturer´s specifications.No staff or patient injury was reported.No other information is available.
Additional Manufacturer Narrative
Complaint not confirmed as there was no returned product for post market quality assurance (pmqa) evaluation.
Additional Manufacturer Narrative
Device history record (dhr) review: serial number: (b)(6) udi: (b)(4) date of manufacture: 1/11/2012 date of installation: on (b)(6) 2012 date of last preventative maintenance (pm): 11/22/2023 date of complaint: on (b)(6) 2023 conclusion: no evaluation was able to be performed.There was no returned product for post market quality assurance (pmqa) evaluation.Without a product to review, the investigation is limited.After the field engineer performed the troubleshooting on 12/14/2023 , no complaints for uncontrolled tube head movement have been submitted for this system.This indicates that adjusting the tomo brake, replacing the vta control board and ribbon cable, and recalibrating the vta resolved the issue.Since the tomo brake had recently been adjusted, the resolution most likely was from replacing the vta control board and/or ribbon cable.With neither the control board nor the ribbon cable, further cause investigation cannot be performed.Cause/root cause: the probable cause was the tomo brake positioning, the vta control board, or the vta drive cable; however, since none were returned, the root cause is unknown.

• 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.; 250 campus drive; marlborough CT 01752
• Manufacturer Contact: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18381387
• Report Number: 1220984-2023-00083
• Device Sequence Number: 12712197
• Product Code: OTE
• UDI-Device Identifier: 15420045505582
• UDI-Public: (01)15420045505582(11)160824
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,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-00001-3D
• Device Catalogue Number: SDM-00001-3D
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 09/02/2024; 09/09/2024
• 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