M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, REVIEW OF THE DEVICE HISTORY RECORDS (DHR). THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. BASED ON DEVICE EVALUATION RESULTS, DAMAGES FOUND ON THE DEVICE WERE LIKELY DUE TO USER MISHANDLING. AS STATED ON THE IFU (INSTRUCTION FOR USE) AND AS A PREVENTIVE MEASURE, THE USER MANUAL STATES : STUDY THIS MANUAL AND OTHER LABELING THOROUGHLY FOR SAFE HANDLING AND STORAGE. MISUSE OF INSTRUMENTS CAN CAUSE INJURY TO THE PATIENT AND COULD HAVE AN ADVERSE EFFECT ON THE PROCEDURE BEING PERFORMED. DO NOT DROP INSTRUMENTS OR ALLOW THEM TO BE STRUCK BY OTHER OBJECTS. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND FOUND DAMAGE TO THE DISTAL TIP, CHIPS AND MOISTURE UNDERNEATH COVER GLASS ON THE EYE CUP. THE DISTAL TIP DAMAGE WAS NOTED TO BE CAUSED BY MISHANDLING. THE CLOUDY IMAGE WAS DUE TO LENS BEING FRACTURED AND MOISTURE ON THE LENS. THE INSTRUCTION MANUAL STATES: "ONLY USE THE TELESCOPE IF THE WRITING IS CLEARLY VISIBLE THROUGH THE TELESCOPE. CHECK THAT THE PRODUCT HAS: NO DENTS, CRACKS, BENDING, OR DEFORMATIONS. NO DEEP SCRATCHES. NO CORROSION. NO LENS DAMAGES OR COVER GLASS DAMAGES. NO MISSING OR LOOSE PARTS" "RISK OF DAMAGE TO THE PRODUCT IF ENDOSCOPES TOUCH EACH OTHER DURING REPROCESSING, TRANSPORT OR STORAGE, DAMAGE TO THE ENDOSCOPE MAY OCCUR. AVOID THAT THE ENDOSCOPES TOUCH EACH OTHER OR OTHER DEVICES DURING REPROCESSING, TRANSPORT OR STORAGE."

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS THAT THERE WAS AN ISSUE WITH THE IMAGE FROM THE DEVICE. NO ADVERSE EVENT REPORTED IN RELATION TO THIS EVENT.