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 device were used in this event , all reported under : 1222780-2021-00282 ,1222780-2021-00283.
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It was reported that on a procedure on (b)(6) the physician reported that he first used a myosure to remove a fibroid on a patient , and then a novasure procedure was performed in which it was observed that the ablation was incomplete and that parts of the endocervical canal had been ablated and lower uterus.The physician at this point decided to perform a second ablation but felt that the sounding device went further into the uterus that the first time and the cavity initial assessment kept failing for which the physician suspected a uterine perforation.3 devices were used in this procedure , 2 novasure devices a 1 myosure device.No other information is available.
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