Lot 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.
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It was reported that after successful completion of a fibroid and device removal, a code blue was called.Patient was under anesthesia during the procedure.According to hologic representative, she was in the hall when the code was called and she saw hospital staff rush into the room "to work on the patient." 911 was called.No further information is available at this time.
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