MalfunctionGCP
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
Received Jun 30, 2026
Report 9610773-2026-04669 · MDR key 25664872
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. DATE OF EVENT IS UNKNOWN, ADDITIONAL INFORMATION WILL BE PROVIDED IF AVAILABLE. BASED ON THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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 ENDOSCOPE TELESCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN IDENTIFIED A CHIPPED LENS. THERE WAS NO PATIENT INVOLVEMENT.