inforMED
MalfunctionGCM

SOLTIVE SUPER PULSED LASER FIBER

Received Feb 3, 2020 · Event occurred Jan 21, 2020

Report 9659259 · MDR key 9659259

Device

Generic name

Endoscope, Rigid

Manufacturer

Gyrus Acmi, Inc.

Model number

TFL-FBX3565S

Lot number

KR869075

Product problems

  • Smoking

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING USE, FIBER AT ATTACHMENT TO MACHINE STARTED TO SMOKE.