D4: 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.H3: 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.
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It was reported that on (b)(6) 2023, the physician initially performed an acessa procedure and completed it successfully without complications.The as the physician was preparing to perform a novasure procedure, in the dilation phase the physician accidentally perforated the uterus, the novasure was not used on the patient only the omni hysteroscope.The physician was unsure if it perforated with the dilator or the hysteroscope.No other information received.
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