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.
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It was reported that on (b)(6) 2021, during an acessa procedure to remove a fibroid.The physician was able to gain a good visualization of the fibroid with ultrasound, the physician placed the array and performed the ablation.At this point it was noticed that one of the points of the array had pierced through the uterus.The physician checked for bowel perforation which was not observed.The physician continued with the procedure and completed the procedure successfully.The patient was not given any post-operative treatment but was asked to return the following day for a checkup.No other information is available.
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