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, the fluid deficit spiked when the scope was inserted.Hologic representative suspected a perforation, but the physician continued with the tissue removal.The first disposable device didn't work so another was opened and used.After the tissue was removed, the physician noted a perforation at the fundus of the uterus.A laparoscopy was performed to confirm.A hemostatic agent was used to stop the bleeding.The patient is recovering fine and hologic representative believes the patient was discharged as planned.
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