VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 14, 2026 · Event occurred Apr 30, 2026
Report 9610773-2026-03770 · MDR key 25174330
Device
Product problems
- Communication or Transmission Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS NOT CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: ERROR 226 OCCURS AND NO IMAGE. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION. THE MOST PROBABLE CAUSE OF THE CONNECTION ERROR B30: INSTRUMENT NOT RECOGNIZED WAS CAUSE NOT DETERMINED AND FOR ERROR 226 OCCURS AND NO IMAGE WAS CAUSE 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 EXHIBITED CONNECTION ERROR B30: INSTRUMENT NOT RECOGNIZED. THE ISSUE WAS FOUND DURING INSPECTION FOR USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.