Lot and 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.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 doctor used the device to remove tissue to increase visibility so he could locate the iud inside the patient cavity.The fluid deficit kept rising.Company representative in operating room at time of the procedure advised the physician that there may be a uterine perforation.Physician stopped using the device but then used forceps and graspers to blindly remove tissue from the patient, still attempting to locate the iud.No iud was found and the company representative stated that "there was lots of blood and there was a mess that lasted 20 minutes." no further information available.
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