MAUDE Adverse Event Report: Hologic, Inc Flourocsan InSight; Image-intensified fluoroscopic x-ray system, mobile

Model Number	InSight FD Refresh
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction

• Brand Name: Flourocsan InSight
• Common Device Name: Image-intensified fluoroscopic x-ray system, mobile
• Manufacturer (Section D): Hologic, Inc; 600 technology dr.; newark DE 19702
• Manufacturer Contact: heather ; 445 simarano drive; marlborough, MA 01752
• MDR Report Key: 50900064
• Report Number: 3005496266-2026-00272
• Device Sequence Number: 17642580
• Product Code: OXO
• UDI-Device Identifier: 15420045509634
• UDI-Public: 15420045509634
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K120388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: InSight FD Refresh
• Device Catalogue Number: InSight FD Refresh
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown