VIDEO-OPTIK "ENDOEYE 3D", 30°
Received May 5, 2026 · Event occurred Apr 22, 2026
Report 9610773-2026-03527 · MDR key 25083673
Device
Product problems
- Crack
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE RIGID VIDEO LAPAROSCOPE HAD A CRACK IN THE LENS, AND THE LENS DETACHED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE FINAL INVESTIGATION. UPDATED FIELDS: D8, H2, H3, H6, H11. 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: DUE TO THE BROKEN CHARGED COUPLED DEVICE, THE RESOLUTION WAS INADEQUATE, DUE TO THE OUTER TUBE HAD A DENT, IT EXHIBITED SHARP EDGES. ADDITIONALLY, FOR THE CRACK ON THE COVER GLASS OF THE INSERTION SECTION, A DEFINITIVE ROOT CAUSE 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.