VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Jul 16, 2026 · Event occurred Jun 25, 2026
Report 9610773-2026-04980 · MDR key 25840556
Device
Product problems
- Fracture
- Poor Quality Image
- Material Split, Cut or Torn
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, IT IS LIKELY THAT THE VIDEO CABLE WAS BROKEN, RESULTING IN STRIPES IN THE IMAGE. FOR THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGED, AND THE (R-UNIT) CHARGED COUPLED DEVICE WAS FOUND TO BE BROKEN, THE MOST PROBABLE CAUSE WAS ATTRIBUTED 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
TTHE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE, WHICH IS AN OLYMPUS-OWNED ASSET, WITH NO REPORTED COMPLAINT. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE VIDEO CABLE WAS BROKEN, RESULTING IN STRIPES IN THE IMAGE. IN ADDITION, THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) WAS DAMAGED, AND THE (R-UNIT) CHARGED COUPLED DEVICE WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.