VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 24, 2026
Report 9610773-2026-03245 · MDR key 24984113
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. DATE OF EVENT IS UNKNOWN, ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE NOT ESTABLISHED. 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 LLK (LASER LIGHT CABLE) PLUG. THERE WAS NO PATIENT INVOLVEMENT.