It was reported that on (b)(6) a myosure and novasure procedure was performed, and at the beginning of the procedure the cavity looked abnormal.The doctor began with the myosure reach to get sampling.Then the doctor opened a novasure v5, but the device would not move out of the red zone.The doctor retracted the device 3 times and tried reseating it.On the 2nd attempt, the width dial jumped to 5 or 6.The doctor removed the novasure device and went in with the scope to check the cavity.It was then noted that there was a perforation.The doctor converted to laparoscopy.No additional information available.
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Device identifier: (b)(4).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.2 devices were involved in this case: 1222780-2024-00033.
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