It was reported that during a procedure on (b)(6) that involved a myosure scope , myosure reach and fluent fluid management system , the patient suffered a bronchial spasm and went into atrial fibrillation.The anesthesiologist was able to stabilize the patient and the procedure was able to be completed.Patient condition is unknown.No other information is available.
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Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are 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.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.3 devices were involved in this event , all were reported under : 1222780-2022-00035 and 1222780-2022-00036.
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