Multiple attempts were made to the facility to obtain further information regarding the patient's condition; however, the user facility did not respond.Upon consultation with the stryker clinical team, consisting of: a senior global medical director, a senior medical safety manager, and a clinical operations director it was determined that the device did not likely cause or contribute to the patient's death for the following reasons: the patient was undergoing a hysteroscopy procedure, which has a potential for respiratory distress and death by air embolism.The thermedx device uses saline, which is unlikely to cause an anaphylaxis reaction.The thermedx device does not use co2 gas, which eliminates the risk for an air embolism.Based on the information provided by the stryker clinical team it was determined that the death was likely caused by anaphylaxis caused by anesthesia or another medication used during surgery, or caused by a venous gas embolism due to the risks associated with the hysteroscopy procedure.
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