MalfunctionGCM
VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received May 11, 2026
Report 9610773-2026-03656 · MDR key 25134393
Device
Product problems
- Scratched Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RIGID VIDEO LAPAROSCOPE OBJECTIVE LENS HAS SCRATCHES. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE EVENT DATE IS UNKNOWN AND WILL BE PROVIDED IF RECEIVED. 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 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.