inforMED
MalfunctionHBI

VITAL VUE

Received Apr 21, 2020 · Event occurred Jul 10, 2019

Report 1282497-2020-00013 · MDR key 9982425

Device

Generic name

Illuminator, Fiberoptic, Surgical Field

Model number

8886828006

Catalog number

8886828006

Lot number

182080012K

Product problems

  • Melted
  • Melted

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BLUE PART OF THE DEVICE HAS HEATED AND MELTED. IT WAS STATED THAT SMOKE APPEARED. THE DEVICE HAS BEEN TURNED OFF. THERE WAS NO PATIENT INJURY.