inforMED
InjuryJOS

SUB MUCOSAL UPP ELECTRODE

Received Nov 7, 2013 · Event occurred Jun 28, 2013

Report 2428235-2013-00004 · MDR key 3560347

Device

Generic name

Submucosal Electrode

Manufacturer

Ellman Int'l Inc.

Model number

TEE229A

Product problems

  • Sparking

Patient

Not reported

  • Ulcer
  • Burn, Thermal

Narrative

Description of Event or Problem

SUBMUCOSAL ELECTRODE SPARKED DURING USE WHICH CAUSED A MINOR BURN IN THE MOUTH. BURN SUBSEQUENTLY CAUSED ULCER.

Additional Manufacturer Narrative

LIMITED INFORMATION AVAILABLE FROM DISTRIBUTOR. DEVICE WAS REQUESTED FOR RETURN BUT HAS NOT BEEN RECEIVED.