MalfunctionFBO
OES CHOLEDOCHO FIBERSCOPE
Received Jul 17, 2025 · Event occurred Apr 7, 2025
Report 9610595-2025-14310 · MDR key 22538750
Device
Product problems
- Material Discolored
- Gas/Air Leak
- Material Deformation
- Optical Problem
- Failure to Clean Adequately
- Material Discolored
- Gas/Air Leak
- Material Deformation
- Optical Problem
- Failure to Clean Adequately
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY DUE TO SOME KIND OF STRESS SUCH AS DAMAGE OR DETERIORATION OF PARTS. THE ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
Description of Event or Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT SUBJECT DEVICE HAD ADHESIVE RESIDUE ON THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.