Evaluation of the scope by, henke sass wolf, found distal damage, bent needle, broken internal optics, and scratches along the needle.Damage was determined to be caused by customer use and/or handling.A device history record review was conducted by the original equipment manufacturer.The service history was reviewed and found no relationship to this failure.Per the instructions for use, the user is advised the following: warnings: -read this manual carefully before you begin work.Follow instructions specifically, giving special attention to warnings, contraindications, controls, features and user specifications.You must be thoroughly familiar with the assembly, use, and care of this device and in all applicable surgical procedures.-before every procedure, carefully inspect the device to ensure it has been properly maintained, is cleaned and sterilized, and is fully functional.Do not use this device if an inspection reveals damage.Precautions: -handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Proper handlings and maintenance: -endoscopes are precision medical instruments and handling them requires great care.1.Do not subject the endoscope to impact.2.Do not bend the shaft.3.Do not bend the shaft after inserting the endoscope into the body.A piece broken off the endoscope can become lodged in the soft tissue or no longer appear in the endoscope's field of vision and thus remain in the body.4.Inspect the endoscope for damage prior to and after each use.If the endoscope is damaged, discontinue use and contact the manufacturer.5.Put the endoscope down carefully.6.Hold endoscope only by the ocular funnel/main part and not by the shaft.7.Transport endoscopes individually and store them safely by using a tray container.This issue will continue to be monitored through the complaint system to assure patient safety.
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