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.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.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), a novasure procedure was performed.Prior to the novasure, the doctor used an omni scope for diagnostic only, no resecting was done.The doctor then performed a curettage procedure.After that was completed the doctor then tried to do a novasure procedure.The cavity assessment kept failing.They made sure there was there was a good cervical seal.The doctor then viewed the cavity and noticed a small perforation.The doctor used an energy tip to cauterize the perforation.The patient required no hospital stay.No additional information available.
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