inforMED
MalfunctionNLW

NA

Received May 24, 2012

Report 2134070-2012-00060 · MDR key 2591243

Device

Generic name

Endoscopic Electrode (nlw)

Manufacturer

Sterilmed, Inc.

Model number

27050G

Product problems

  • Arcing

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT WHILE BEING USED DURING A PROCEDURE, AN ENDOSCOPIC ELECTRODE ARCED.

Additional Manufacturer Narrative

FINAL INVESTIGATION SHOWED THAT THE DEVICE WAS DAMAGED. THE INSULATION ON THE DISTAL TIP WAS BURNT AND MELTED, AND THE DEVICE WAS ALSO BENT AT A NOTICEABLE ANGLE.