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.Two devices involved in this event reported under 1222780-2022-00032.
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It was reported that during a myosure procedure on (b)(6) 2022 , the physician observed that the deficit was rising very quickly up to 1500 ml , a uterine perforation was suspected.It is unknown if the procedure was completed.A omni 6 mm scope was also used during the procedure.No other information is available.
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