VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 14, 2026 · Event occurred Jun 12, 2026
Report 9610773-2026-04914 · MDR key 25812029
Device
Product problems
- Break
- Fracture
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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, FIBRE BONDING IN THE OUTER TUBE AREA DISTAL END IS DAMAGED. MENISCUS OF THE R-UNIT (CHARGED COUPLED DEVICE) SECTION IS BROKEN; UNIT IS BROKEN AND THEREFORE THE RESOLUTION IS INADEQUATE, WAS OBSERVED. THE SERVICE REPAIR CENTER INDICATED THAT THE MOST LIKELY CAUSE OF FIBER BONDING IN THE OUTER TUBE AREA DISTAL END IS DAMAGED, MENISCUS OF THE R-UNIT SECTION IS BROKEN; UNIT IS BROKEN AND THEREFORE THE RESOLUTION IS INADEQUATE. THE WAS DUE TO IS TRACED TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
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, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION THE MOST PROBABLE CAUSE OF FIBER BONDING IN THE OUTER TUBE AREA DISTAL END IS DAMAGED IS TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF MENISCUS OF THE R-UNIT (CHARGED COUPLED DEVICE) SECTION IS BROKEN IS TRACED TO COMPONENT FAILURE. THE MOST PROBABLE CAUSE OF R-UNIT IS BROKEN AND THEREFORE THE RESOLUTION IS INADEQUATE IS 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.