VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 26, 2026 · Event occurred May 5, 2026
Report 9610773-2026-04067 · MDR key 25275048
Device
Product problems
- Break
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 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, COVERGLASS OF THE INSERTION SECTION IS CRACKED, THE MENISCUS OF THE CHARGED COUPLED DEVICE SECTION IS BROKEN WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE COVERGLASS OF THE INSERTION SECTION IS CRACKED, THE MENISCUS OF THE CHARGED COUPLED DEVICE SECTION WAS DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.