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 on october 12th during a myosure procedure , it was reported that the patient had a previous history of a hysterectomy , it is unknown when or if it was total or subtotal , the physician used a myosure to resect and the reported that the patient must have had a previous hysterectomy.It was reported that the patient suffered a bladder injury and that an urologist was called in.No additional information could be obtained regarding the previous history of the patient , the patient was scheduled for a hysteroscopy d&c with myosur a laparoscopy and cystoscopy was performed due to complications.No additional information available.
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