MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 23, 2026 · Event occurred Jan 12, 2026
Report 9610773-2026-03225 · MDR key 24971404
Device
Product problems
- Poor Quality Image
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE. 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 THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE EXHIBITED FAILED LIGHT SOURCE AND FAILED 3D (THREE DIMENSIONAL) IMAGE. THERE WAS NO PATIENT INVOLVEMENT.