Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Serial number of the myosure control unit and hysteroscope not provided by the complainant.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.Event problem and evaluation codes: the device was received and gross visual examination of the return product revealed evidence of a blade exit during procedure.The distal tip was bent backwards there was strike marks and fragmented damage to the blade.This type of finding appears to be user related.Devices are also 100% visually inspected for blade damage prior to final release.This observation will be monitored and trended.Reference internal complaint (b)(4).
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