Lot and serial number of the disposable 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.Lot 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 disposable device as the identification numbers were not provided by the complainant.Internal reference #: (b)(4).
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It was reported that during the procedure, prior to inserting the myosure device, the fluid deficit began to rise.The myosure device was inserted into the patient and the deficit continued to rise.They aborted the procedure when the deficit reached 1650 ml.The physician viewed the uterus via laparoscopy and noted the fundus was perforated.He put one stitch to seal the perforation.The patient was doing fine when hologic representative left the or.
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