MAUDE Adverse Event Report: HOLOGIC, INC. FLOUROCSAN INSIGHT; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Patient Problem Insufficient Information (4580)

Event Date 06/05/2023

Event Type  malfunction  

Event Description

During a hand surgery, the hand control on the hologic fluoroscan insight fd mini c-arm did not work for the surgeon.Surgeon was not able to perform stress radiography.Patient discharged home day of surgery.Unknown if patient harm at this time.

• Brand Name: FLOUROCSAN INSIGHT
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 17669329
• MDR Text Key: 322480644
• Report Number: 17669329
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Date Report to Manufacturer: 09/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA