inforMED
OtherFSH

VALLEYLAB

Received Apr 4, 2007 · Event occurred Mar 16, 2007

Report 836197 · MDR key 836197

Device

Generic name

Microsurgical Needle

Manufacturer

Valleylab

Model number

E1651

Catalog number

*

Lot number

114827

Product problems

  • Cautery
  • Insulation failure
  • Arcing

Patient

49 YR

  • Burn(s)
  • Tissue Damage
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

PT SCHEDULED FOR LOWER LID BLEPHAROPLASTY. DURING PROCEDURE, THERE WAS AN "ARC" FROM THE CAUTERY TIP. THERE WAS ADD'L CAUTERY TO TISSUE THAT NEEDED TO BE REMOVED. IT IS UNK AT THIS TIME IF THE SURGICAL OUTCOME WAS AFFECTED.