MalfunctionFSZ

PHOTONGUIDE

Received Feb 14, 2024 · Event occurred Dec 29, 2023

Report 18702788 · MDR key 18702788

Device

Generic name

Light, Surgical, Carrier

Manufacturer

Stryker Corporation

Model number

104015

Lot number

23144W

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

THE MOST RECENT BURNING/MELTING OF THE PHOTONGUIDE INVOLVED A LED LIGHT SOURCE AS OUTLINED IN THE MANUFACTURER'S IFU. THIS IS THE FOURTH INCIDENT INVOLVING THIS DEVICE, WHILE THE PREVIOUS 3 INVOLVED A XENON LIGHT SOURCE. DUE TO PATIENT RISK, THE HOSPITAL IS NO LONGER UTILIZING THE PRODUCT AND HAS ENGAGED THE MANUFACTURER REGARDING THE TOTAL REMOVAL OF THE DEVICE.