MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D INTL-MOBILE

Model Number	3DM-SYS-INTLD2D-MOB
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device identifier: (b)(4).
Event or Problem Description
It was reported that on (b)(6), 2023 the c-arm was found in a low position while the staff were outside, as if it moved down on its own.The field engineer examined the equipment and found that the footswitch was stuck, the field engineer replaced the footswitch, and the device was tested and performed as expected.The device is working as the manufacturer´s specifications.
Additional Manufacturer Narrative
Investigation was completed and: on 12/20/2023, 3dimensions serial number (b)(6), a customer reported to hologic that there was uncommanded c-arm movement.The c-arm allegedly moved to a lower position while the staff was outside.The system displayed a pmc 38:54 ¿stuck switch fault ¿ right foot switch disabled¿ error.There were no health consequences due to the occurrence.The system was able to be used after power-cycling the gantry.The field service engineer (fse) replaced both footswitches (left and right).The 3dimensions then performed normally after the troubleshooting according to the fse.Investigation methods and findings: the replaced part was scrapped on site, so no initial evaluation could be performed.Since the footswitch was scrapped, the investigation is limited.Footswitches were requested from the field for comparable sample collection; however, no samples were received that caused uncommanded motion.Further investigation into root cause is not possible at this time.The probable cause is that the footswitch malfunctioned since the unintended behavior was resolved through replacing the footswitch.The root cause is unknown due to the unreturned part.Based on this investigation, the probable cause is that the footswitch malfunctioned, and the root cause is unknown due to the unreturned part.The risk index remains in zone 1 with a ri of 1.This is considered acceptable risk a capa is not needed at this time as there was no patient or user harm and because the risk is considered low based on the occurrence rate.Future events will be monitored and trended.Complaint confirmed: no.Device history record (dhr) review: udi: (b)(4), date of manufacture: 12/30/2019, installation date: (b)(6) 2020, closest pm to complaint date: 11/2/2023; complaint date: 12/20/2023; date of part manufacture: unknown ¿ part was not received for investigation.There is no record of previously replaced footswitches on this system, so the dhr was reviewed.Both footswitches (and all four pedals on each) were tested and worked during manufacturing.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D INTL-MOBILE
• 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18489054
• Report Number: 1220984-2024-00001
• Device Sequence Number: 15250959
• Product Code: OTE
• UDI-Device Identifier: 15420045510593
• UDI-Public: (01)15420045510593(11)191230
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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: 3DM-SYS-INTLD2D-MOB
• Device Catalogue Number: 3DM-SYS-INTLD2D-MOB
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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