Ethicon—ENSEAL X1 Curved Jaw Tissue Sealers: Intraoperative Bleeding May Occur
May 22, 2019 | Risk Management News
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In a May 15, 2019, Urgent Medical Device Recall Removal letter submitted by an ECRI Institute member hospital and an Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Ethicon states that it has observed a reported incident rate for the above products for harm associated with intraoperative bleeding that does not meet Ethicon's performance standards. Ethicon also states that it has received several reports that the above products may not achieve expected hemostasis. Ethicon further states that it has received one report of serious injury (death) that...