inforMED
MalfunctionFSZ

EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER

Received Jun 17, 2021 · Event occurred Feb 12, 2020

Report 12016315 · MDR key 12016315

Device

Generic name

Light, Surgical, Carrier

Manufacturer

Invuity, Inc.

Model number

NARROW / FLAT

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

Not reported

  • Superficial (First Degree) Burn
  • Superficial (First Degree) Burn

Narrative

Description of Event or Problem

SURGEON WAS USING EIKON LIGHT WITH PHOTONGLIDE NARROW/FLAT ADAPTER PIECE. AFTER TURNING THE LIGHT SOURCE ON DURING SURGERY, THE ADAPTER PIECE MALFUNCTIONED AND BURNED THE SURGEON'S HAND. THE SURGEON DE-GOWNED AND REMOVED HIS GLOVES BUT DECLINED ANY FURTHER MEDICAL ASSISTANCE FOR THE BURN. IT WAS DEEMED APPROPRIATE TO REPLACE THE AFOREMENTIONED LIGHT ADAPTER. THE SURGEON SCRUBBED BACK INTO THE CASE, AS STERILITY WAS MAINTAINED THROUGHOUT THE INCIDENT. THE MALFUNCTIONING PIECE WAS EXAMINED BY THE CIRCULATOR AND CERTIFIED SURGICAL TECHNOLOGIST (CST), THEN GIVEN TO THE CIRCULATOR'S CLINICAL MANAGER FOR FURTHER INVESTIGATION/FOLLOW UP WITH THE MANUFACTURER.