Serial number of the device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.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 "prior to the procedure the doctor used a sound, dilator and curettage.The doctor noticed that the deficit began to increase.A pressure bag was used as fluid management.The doctor noticed on the screen that there was a perforation.The procedure was aborted." the disposable device was never used, only the scope.No additional details available.
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