inforMED
MalfunctionFSX

PHOTONGUIDE, WIDE/FLAT

Received Dec 11, 2020 · Event occurred Oct 22, 2020

Report MW5098341 · MDR key 11010486

Device

Generic name

Light, Surgical, Carrier

Manufacturer

Invuity, Inc.

Model number

Wide / Flat

Catalog number

104015

Lot number

AB20013104

Product problems

  • Melted

Patient

46 YR

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BULB MELTED DURING PROCEDURE. FDA SAFETY REPORT ID# (B)(4).