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 myosure reach procedure, the physician went into the uterine cavity and performed a resection of a polyp, and did a hysteroscopy, then used a sounding device, after this the physician performed a new hysteroscopy and observed a uterine perforation.The physician confirmed that the perforation occurred due to the sounding device.The myosure reach was used and the hysteroscope inside the uterine cavity.The patient was kept 24 hours for observation and no additional procedures were performed.No other information is available.
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