N
Patient 1
THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND FOUND THE SCOPE?S BENDING SECTION WAS NOT IN A STRAIGHT POSITION. THERE WAS UP AND DOWN MOVEMENT WHEN MANIPULATED; HOWEVER, THE BENDING SECTION WOULD NOT STRAIGHTEN WHICH CONFIRMED THE USER IS EXPERIENCE. THE DISTAL END WAS INSPECTED AND NOTED THERE IS METAL EXPOSED AND METAL PROTRUDING THE BENDING SECTION COVER. THE BENDING SECTION COVER WAS REMOVED AND FOUND THE SCOPE?S SKELETON BROKEN CAUSING THE BENDING SECTION NOT TO BE IN A STRAIGHT POSITION. THERE WERE KINKS NOTED AT THE TOP SECTION OF THE INSERTION TUBE NEAR THE BENDING SECTION. ADDITIONALLY, THE SCOPE?S IMAGE WAS INSPECTED AND NOTED 7 BROKEN FIBERS (BLACK DOTS) WERE FOUND ON THE IMAGE. A REVIEW THE INSTRUMENT HISTORY SHOWED THE SCOPE WAS PURCHASED ON JULY 8, 2017 AND RETURNED FOR REPAIR DECEMBER 21, 2017, DUE TO DAMAGE ON THE INSERTION TUBE. BASED ON THE EVALUATION, THE USER?S COMPLAINT WAS CONFIRMED AS THE SCOPE?S BROKEN SKELETON IS LIKELY DUE TO MISHANDLING. THE INSTRUCTION MANUAL PROVIDES THE USER SEVERAL WARNINGS IN THE ?IMPORTANT INFORMATION ? PLEASE READ BEFORE USE? SECTION TO MITIGATE DAMAGE TO THE SCOPE. THE RELATED WARNINGS ARE AS FOLLOWS: DO NOT HIT TO THE DISTAL END OF THE INSERTION TUBE OR ALLOW IT TO STRIKE OTHER OBJECTS. THE OBJECTIVE LENS SURFACE OF THE DISTAL END IS PARTICULARLY FRAGILE, AND VISION ABNORMALITIES MAY RESULT. DO NOT TWIST OR BEND THE BENDING SECTION BY HANDS. EQUIPMENT DAMAGE MAY RESULT. DO NOT SQUEEZE THE BENDING SECTION FORCEFULLY. THE COVERING OF THE BENDING SECTION MAY STRETCH OR BREAK AND CAUSE WATER LEAKS.