MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 27, 2026 · Event occurred Mar 13, 2026
Report 9610773-2026-03300 · MDR key 25001783
Device
Product problems
- Failure to Clean Adequately
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 WAS CAUSE NOT DETERMINED. 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 FOREIGN MATERIAL IN THE LASER LIGHT CABLE PLUG OF THE VIDEO CABLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.