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

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on may 21, the face shield of the system cracked due to normal use and the mammography technician cut her hand on the sharp plastic edges of the plastic 3d mammo face shield.The technician did not require hospitalization.A field engineer examined the device and confirmed that the face shield was cracked and replaced the face shield.No additional information available.
Additional Manufacturer Narrative
Device history record review: date of face shield installation on (b)(6) 2023.Date face shield cracked on (b)(6) 2024.Udi: (b)(4).The face shield was not returned for investigation.The field engineer who replaced the cracked face shield was contacted to see if they had the face shield.The field engineer indicated that they no longer had the face shield, and it was disposed of.Complaint not confirmed as there was no returned product for post market quality assurance (pmqa) evaluation.
Additional Manufacturer Narrative
Investigation closed: the face shield was not returned for investigation.The fe who replaced the cracked face shield was contacted to see if they had the face shield.The fe indicated that they no longer had the face shield, and it was disposed of.The notes within the complaint states: the mammography technician cut her hand on the sharp plastic edges of the face shield.She did not require hospitalization.The complaint is reportable, harm to the user has been identified.Based on the description of the complaint and the as reported code.The most probable cause is linked to the ongoing cracked face shield investigation: a capa was opened to investigate this issue: investigation into cracking face shields.This capa will identify the root cause of face shields cracks and implement an action plan to reduce the occurrence rate.A risk assessment trending was performed and the probability was calculated at 1 (very low) the complaint for cracked face shield was not retuned for investigation and cannot be confirmed.Based on the description and events that occurred, most likely will be tied to the root cause to be determined via capa opened.Device history record (dhr) review: dimensions ¿ asset sdm-sys-9000-3d | (b)(6), face shield component replaced fab-03473, date of face shield installation (b)(6)2023, date face shield cracked (b)(6)2024.Udi (b)(4).

• 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; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: cathleen hargreaves ; 562 parkway; coyol free zone building b24; san jose, MA 20102
• MDR Report Key: 19463264
• Report Number: 1220984-2024-00052
• Device Sequence Number: 20517121
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)170318
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 10/09/2024; 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown