NA 7207398Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010427403), received between Aug 17, 2019 and Aug 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unexpected Shutdown” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2019Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING THE SURGERY THE LIGHT SOURCE AUTOMATICALLY SWITCHED OFF DURING THE PROCEDURE CAUSING A COMPLETE LOSS OF IMAGE. AFTER A SMALL AMOUNT OF TIME WITH THE UNIT OFF, THEY REMOVED THE MODULE TO FIND SOME BURN MARKS THAT COULD HAVE OCCURRED ON THE DEVICE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8904310 ↗