LITe DECOMPRESSION 48089999Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327064926), received between May 10, 2016 and Jul 5, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2016Thermal Decomposition of Device; Device Emits Odor; Material Deformation; Material Deformation

  IT WAS REPORTED THAT; NOTICED SMELL COMING FROM LIGHT SOURCE. WHEN I PULLED OUT LIGHT CABLE NOTICE IT WAS BURNED. I MEDIATED DISCONNECTED AND INSERTED NEW LIGHT CABLE IN NEW LIGHT SOURCE UNIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5769473 ↗
• MalfunctionMay 10, 2016Charred; Device Emits Odor; Sparking; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; SMELL WAS COMING OUT OF LIGHT SOURCE. WE SWITCHED TO NEW A SOURCE. NOTICE END OF LIGHT CABLE WAS CHARRED. WHEN WE SWITCHED LIGHT UNITS THE SMELL DISSIPATED. FEW MIN LATER, SURGEON PULLED OUT LIGHT CABLE FROM LIGHT DECOMPRESSION TUBE IMMEDIATELY. SAID IT SPARKED. UPDATE (B)(6) 2016: SURGEON SAID HE SAW A SPARK INSIDE TUBE WHICH WAS IN PATIENT. USED REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5645359 ↗