inforMED
MalfunctionFSO

OPMI LUMERA 300

Received Nov 13, 2020 · Event occurred Oct 15, 2020

Report 3008564898-2020-00002 · MDR key 10840524

Device

Generic name

Microscope, Surgical

Model number

OPMI LUMERA 300

Catalog number

6137

Product problems

  • Insufficient Device Problem Information
  • Patient Device Interaction Problem
  • Insufficient Device Problem Information
  • Patient Device Interaction Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H6: MEDICAL DEVICE PROBLEM CODE CHANGED TO 4001; INVESTIGATION FINDINGS CHANGED TO 213; INVESTIGATION CONCLUSIONS CHANGED TO 67.

Additional Manufacturer Narrative

THERE WAS NO ADVERSE EVENT IN THIS CASE. NO SERIOUS INJURY, DEATH OR UNREASONABLE RISK OF SUBSTANTIAL HARM TO THE PUBLIC HEALTH. ROOT CAUSE NOT CLEAR YET, NEED FURTHER INVESTIGATION TO DETERMINE IF THIS IS AN APPLICATION ISSUE (USER ERROR). REQUEST THE RETURN OF THE OPMI FOR DOUBLE CONFIRMATION OF THE RED REFLEX FUNCTION.

Description of Event or Problem

A CUSTOMER IN CYPRUS COMPLAINED ABOUT THE RED REFLEX FUNCTIONALITY NOT WORKING. THE RED FLEX WAS OK WHEN STARTING THE SURGERY AND THEN IT WAS DISAPPEARING. EITHER BY ITSELF OR MOVING IT THE RED REFLEX WAS REAPPEARING. THE SYSTEM WAS OK FOR 2-3 OPERATIONS IN A ROW AND THEN RED REFLEX WAS DISAPPEARING. NO ONE WAS HURT IN THIS CASE BUT SURGERY HAS BEEN CANCELLED DUE TO THIS ISSUE.