MalfunctionGCM
VIDEO-OPTIK "ENDOEYE 3D", 30°
Received Jul 13, 2026 · Event occurred Jun 17, 2026
Report 9610773-2026-04898 · MDR key 25798999
Device
Product problems
- Break
- Dent in Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, COMPONENT FAILURE LED TO THE MALFUNCTION. 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
THE CUSTOMER RETURNED THE RIGID VIDEO LAPAROSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING THE REPAIR CENTER TECHNICIAN FOUND DENT ON OUTER TUBE WITH BROKEN R-UNIT. THERE WAS NO PATIENT INVOLVEMENT.