Evaluation summary: post market vigilance (pmv) led an evaluation of one hysteroscope.A visual inspection was performed and showed the distal cover glass is scratched and leaky, dented outer tube, sheath is bent, severe distal tip damage, and a damaged leaky stopcock.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures; therefore, a device history record will not be performed.The root cause of the observed condition was determined to be a result of a misuse of the product.The information 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.Based on the evidence available the reported condition was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
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