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.
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It was reported that during a procedure performed on (b)(6) 2020, doctor attempted to place a myosure hysteroscope in the patient and could not move forward.At that time, myosure scope was removed, continued to dilate the patient, and switched to a non-hologic scope at which point a uterine perforation was discovered and immediately terminated the hysteroscopy and procedure.No myosure cutting devices were opened or used.Final deficit approximately 450cc.No other details were provided.
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