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

Model Number	3DM-SYS-INTL3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: component code: appropriate term/code not available: suggested code : brakes.
Event or Problem Description
It was reported that during a 3dimensions procedure on (b)(6) 2024, when moving the c-arm to 90° angle, it was reported that the c-arm was randomly over rotating to 92° without any type of command.Error message/code vta (29:14) was displayed during the incident (issued when the measured carm/tomo motion is slow or in the wrong direction).The incident occurred prior procedure with no patient in the room.No injury was reported to the user/staff.A field engineer examined the equipment and it was determined that the error could not be reproduced but the rot potentiometer was replaced and the brakes were additionally replaced and the anti-backlash brake plates.The system met the manufacturer´s specifications.
Additional Manufacturer Narrative
On 11/27/2024, our customer reported an incident with our 3dimensions mammography system (serial number (b)(6)).When moving the c-arm to 90° angle, it was reported that the c-arm was intermittently over-rotating to 92° without any type of command.Error message/code vta (29:14) was displayed during the incident.The incident occurred prior to procedure with no patient in the room.No injury was reported to the user/staff.The field service engineer (fse) could not reproduce the error.However, when replacing the c-arm angle potentiometer, the tomo brake was found to be loose and moved when rotating the c-arm.This tomo brake, anti-backlash gears (upper and lower), and power supply cable were replaced.The fse found that the system was working as expected after the troubleshooting.Initial evaluation: the parts are no longer available to return for investigation.They were either scrapped on site or sent for recycling.All the parts were 531 days old from the date of system manufacturing, except for the c-arm angle potentiometer which was 7 days old since the previous replacement.Investigation methods and findings: error code vta (29:14) is issued when the measured c-arm/tomo motion is slow or in the wrong direction.A review of the prior history showed that there were a couple of complaints related to noisy c-arm rotation.The first complaint of a vta 29:14 error code and over-rotation for this system was on 11/20/2024.To troubleshoot, the fse replaced the c-arm angle potentiometer and tightened the magnetic brakes (which includes the tomo brake).The behavior returned a week later.The fse found that the tomo brake was loose.After replacing the tomo brake, anti-backlash gears (upper and lower), and power supply cable, a complaint review showed that the over-rotation and vta errors have not recurred.Further investigation cannot be carried out due to the lack of part return.Cause/root cause: the probable cause is the loose tomo brake; however, the root cause for why the brake loosened is unknown.Further root cause investigation is not possible due to the unreturned part.Conclusion: in summary, the root cause is unknown, and the probable cause is that the tomo brake continued to become loose.This was resolved by replacing the tomo brake and a few other components.This behavior has not recurred since the troubleshooting.The risk index (ri) remains in zone 1 with a ri of 1.This is considered acceptable risk.A capa is not needed at this time as there were no patient or user harm and because the risk is considered low based on the occurrence.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4), sku: 3dm-sys-intl3d, serial number: (b)(6), gantry number: (b)(6), date of manufacture: 6/15/2023, installation date: (b)(6) 2023, incident date: (b)(6) 2024, closest pm to complaint date: 9/25/2024, date of part manufacture: unknown.Review of past history: complaint on 11/10/2023 - noisy movement to 90 degrees.This was resolved by adjusting the covers.Complaint on 6/21/2024 - noisy movement when rotating.The fse was unable to reproduce the behavior.Complaint on 11/20/2024 ¿ vta 29:14 errors when taking lateral exposures at 90 degrees.The fse replaced the c-arm angle potentiometer and tightened the screws on the magnetic brakes (including tomo brake).Because the probable cause parts were original, the dhr will be reviewed.Dhr review summary: a review of the discrepancies found none that were related to c-arm rotation or vta errors.

• 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; alajuela 20102
• MDR Report Key: 21011459
• Report Number: 1220984-2024-00149
• Device Sequence Number: 8342244
• Product Code: OTE
• UDI-Device Identifier: 15420045510579
• UDI-Public: (01)15420045510579(11)230615
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 3DM-SYS-INTL3D
• Device Catalogue Number: 3DM-SYS-INTL3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/24/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2023
• 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