LIGHT SOURCE, LUMERA 100-125V
Received May 18, 2021 · Event occurred Oct 21, 2020
Report 11840749 · MDR key 11840749
Device
Generic name
Light, Ultraviolet, Dermatological
Manufacturer
Daavlin Co.Model number
LUMERACatalog number
951CTLS
Product problems
- Therapeutic or Diagnostic Output Failure
Patient
25185 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
PATIENT WAS BROUGHT INTO ROOM AND PREPARED FOR CATARACT EYE SURGERY. WHEN CLINICIANS WERE READY TO MAKE AN INCISION, THE MICROSCOPE LIGHT TURNED OFF. THE LIGHT DID NOT TURN ON WHEN PLACED IN THE SURGEON¿S DESIRED LOCATIONS. ALL LOCATIONS WERE CHECKED AND THE COMPANY REPRESENTATIVE WAS CALLED TO GET ADVICE, BUT THE EQUIPMENT MALFUNCTIONED AND CASES WERE CANCELLED FOR THIS PATIENT AND FOR THE REST OF THE DAY. THE LAMP MODULE WAS REPLACED LATER BY THE REPAIR VENDOR, AND THE UNIT WAS RETURNED TO SERVICE. THIS IS ASSOCIATED WITH (B)(6).