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

Model Number 3DM-SYS-STD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Neck Pain (2433)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that on january 9th, a mammography procedure was performed and the staff was attempting to rotate the gantry with the buttons on the c-arm, and the c-arm began to turn the other way.It did not stop until the gantry was upside down and the user was hit in the back of the neck with the gantry when this occurred.The user was sore but did not seek medical attention.The field engineer inspected the switches and cables, looked for foreign matter inside the c-arm, and was unable to reproduce the issue, tested the system with the specifications, and the system met the manufacturer´s specifications.No additional information available.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Type of Device: 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 ; CR 20102
• MDR Report Key: 18581281
• MDR Text Key: 333742199
• Report Number: 1220984-2024-00006
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3DM-SYS-STD
• Device Catalogue Number: 3DM-SYS-STD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other