Evaluation summary post market vigilance (pmv) led an evaluation of one device.Complaint of broken piece from mdu stuck in control unit's receptacle was confirmed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the observed condition was determined to be a result of a misuse of the product.Damage may occur if the headpiece 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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