Evaluation summary: post market vigilance (pmv) led an evaluation of one device.A visual inspection was performed and showed a dented outertube, the outertube is jolted, laser welding damage, and the stopcock is damaged and leaky.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The instruction for use recommends ¿careful inspection of the operative hysteroscope before and after the procedure for possible signs of damage.Immediate detection and repair of minor damage will extend the life of the operative hysteroscope.¿ damage may occur if the hysteroscope is handled roughly during use.Excessive forces may result in traumatic insertion, chipping particles of the optical glass, or other damage to the unit.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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