GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND THE RESULTS OF THE DEVICE HISTORY RECORDS (DHR) REVIEW. THE DHR FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE INSPECTION RESULT, PHYSICAL DAMAGE FOUND ON THE DEVICE WAS MOST LIKELY DUE TO USER MISHANDLING. THE DEVICE INSTRUCTIONS FOR USE PROVIDES WARNINGS AND CAUTIONS TO ALERT THAT THE DEVICE MAY BE DAMAGED BY IMPROPER HANDLING. IT 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."

Additional Manufacturer Narrative

THIS SUPPLEMENT IS BEING SUBMITTED TO CORRECT THE MODEL NUMBER AND UDI NUMBER PER LEGAL MANUFACTURER REVIEW OF DEVICE HISTORY REPORT.

Additional Manufacturer Narrative

THE SUSPECT DEVICE HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. UPON INITIAL INSPECTION, THE OLYMPUS SERVICE CENTER CONFIRMED THE OUTER TUBE WAS BENT AND THE INTERNAL LENSES WERE CRACKED, CAUSING A LOSS OF IMAGE. DEBRIS UNDER EYEPIECE WINDOW WAS ALSO OBSERVED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

Description of Event or Problem

IT WAS REPORTED TO OLYMPUS, THE DEVICE SHAFT WAS BENT AND THERE WASN'T AN IMAGE. THE MALFUNCTION WAS IDENTIFIED IN REPROCESSING ON (B)(6) 2021. NO PATIENT INVOLVEMENT.