VIDEO TELESCOPE "ENDOEYE 3D", 10 MM, 0°
Received Apr 30, 2026
Report 9610773-2026-03404 · MDR key 25042374
Device
Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE RIGID VIDEO LAPAROSCOPE DOES NOT RENDER IN 3 DIMENSIONAL, NOT ABLE TO WHITE BALANCE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Additional Manufacturer Narrative
E1 FULL ESTABLISHMENT NAME DUE TO CHARACTER LIMIT: (B)(6). 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: THE VIDEO CONNECTOR COVER WAS DAMAGED, THE VIDEO CONNECTOR COVER WAS CRACKED, THE OBJECTIVE LENS WAS CONTAMINATED, IMAGE MISALIGNMENT, POOR RESOLUTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED WHEREAS IT IS PRESUMED THAT THE ADDITIONAL REPORTABLE FINDING OCCURRED DUE TO COMPONENT FAILURE OF THE CHARGED COUPLE DEVICE, COMPONENT FAILURE OF THE VIDEO CONNECTOR COVER, AND COMPONENT FAILURE OF THE OBJECTIVE LENS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.