OPMI PENTERO

Additional Manufacturer Narrative

H3: OTHER REASON WHY DEVICE WAS NOT EVALUATED: SERIAL NUMBER IS UNKNOWN. ACCORDING TO THE ZEISS FIELD SERVICE ENGINEER, THE CUSTOMER MIGHT LACK TRAINING AND MAY HAVE USED A HIGH INTENSITY OF XENON LIGHT. THE ROOT CAUSE OF THE REPORTED EVENT WAS A USER ERROR DUE TO HIGH INTENSITY OF XENON LIGHT USED, AND INEXPERIENCE OF THE SURGEON WHO PERFORMED THE PROCEDURE.

Description of Event or Problem

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT SUSTAINED A THIRD DEGREE BURN WHICH WAS DISCOVERED DURING A FOLLOW-UP TREATMENT ONE MONTH AFTER THE INITIAL SURGERY. AN AFTER-TREATMENT OF THE BURN WITH DEBRIDEMENT AND PRIMARY CLOSURE WAS NECESSARY.