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.