VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Apr 20, 2026 · Event occurred Mar 23, 2026
Report 9610773-2026-03123 · MDR key 24925156
Device
Product problems
- No Display/Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1- PHONE NUMBER (B)(6). THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: ERROR E216 APPEARS, THE FIBER BONDING IN THE OUTER TUBE AREA (DISTAL END) IS DAMAGED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS LIKELY THAT THE REPORTABLE MALFUNCTION WAS TRACED DUE TO THE VIDEO CABLE IS BROKEN AND THEREFORE THE IMAGE IS NOT DISPLAYED AND ERROR E216 APPEARS., AND ADDITIONALLY, THE MOST PROBABLE CAUSE FOR THE FIBER BONDING IN THE OUTER TUBE AREA DISTAL END IS DAMAGED. 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
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE DISPLAYED NO IMAGE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.