PENTAX Medical ultrasound endoscopes and water bottle assembly

Issue

Pentax Medical has received an information related to a reported patient death in connection with a case in which air unintentionally entered the balloon attached to the distal end of an ultrasound endoscope during an endoscopic ultrasonography procedure.As a result of the investigation, a definitive causal relationship between the ingress of air into the balloon and the patient's death could not be established. However, it also cannot be completely ruled out. Therefore, to clearly address this potential risk, Pentax Medical has added a new warning to the IFU for the relevant ultrasound endoscopes and the water bottle assembly. This additional warning will be included in the IFU of all newly manufactured devices. For devices already placed on the market the users shall add this field safety notice to their documentation and inform their staff accordingly.As this issue may, under certain circumstances, potentially lead to a serious adverse event, Pentax Medical provides the following information to all customers using ultrasound endoscopes to ensure continued safe use of our products.