inforMED
MalfunctionFSZ

PHOTONGUIDE

Received Aug 5, 2021 · Event occurred May 13, 2021

Report 12280154 · MDR key 12280154

Device

Generic name

Light, Surgical, Carrier

Manufacturer

Invuity, Inc.

Product problems

  • Break

Patient

14965 DA

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

Narrative

Description of Event or Problem

DURING A LUMPECTOMY PROCEDURE, IT WAS NOTED THAT THE PLASTIC DISPOSABLE END PIECE OF THE PHOTONGUIDE HAD BROKEN OFF AND THE LIGHT, FROM THE BREAST RETRACTOR, BURNED THE SKIN OF THE PATIENT. THE BROKEN PIECE WAS FOUND ON THE SURGICAL DRAPE AND PASSED OFF THE FIELD. THE LIGHT RETRACTOR WAS IMMEDIATELY TURNED OFF. THE SURGEON ASSESSED THE BURN, AND APPLIED BACITRACIN OINTMENT AT THE END OF THE PROCEDURE.