inforMED
MalfunctionCCW

GREENLINE G-MAC 3 BLADE

Received Dec 27, 2013 · Event occurred Nov 4, 2013

Report 3543637 · MDR key 3543637

Device

Generic name

Laryngoscope, Rigid

Model number

G-MAC 3

Catalog number

5-5272-03

Lot number

*

Product problems

  • Electrical /Electronic Property Problem
  • Component Missing

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THERE WERE 2 BALL-BEARING MISSING. THE CONCERN IS THAT SOME OF THESE BALLS MAY BE LOOSE AND LOST IN THE AIRWAY. ALSO, WITHOUT A BALL BEARING THE LARYNGOSCOPY LIGHT MAY NOT TURN ON. THIS IS HOW THE PROBLEM WAS DISCOVERED.THESE LARYNGOSCOPY BLADES HAVE BEARING-BALLS FOR SECURING THE BLADE TO THE LARYNGOSCOPY HANDLE. THE PROBLEM WAS DISCOVERED BECAUSE THE LIGHT OF THE LARYNGOSCOPE COULD NOT TURN ON. THERE WAS NO PATIENT HARM IN THIS EVENT.THERE IS CONCERN THAT THE STERILIZING PROCESS FOR THE BLADES (WHICH INVOLVES HEAT CHANGES) MAY DAMAGE THE BLADE BEARING-BALL.