Serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Serial number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the device as the identification numbers were not provided by the complainant.
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It was reported that during a polyp removal procedure, a false passage was created.The hysteroscope was removed and re-inserted but there was poor visualization.A mass was resected by the physician that was thought to be a polyp.Upon removal of the scope, bleeding was noted.The physician thought she may have "snipped" the cervix.Ultimately, it was determined that the physician perforated the vaginal wall.A laparoscopy was performed to stitch the patient from the inside.The patient was kept overnight for observation.No further information provided.
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