Device identifier: (b)(6).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.H3: 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 december 21st a hysteroscopy was performed and during the procedure the deficit was at 1280 ml, when staff went to change the saline bag the deficit increased to over 3000 ml.The scope was outside of the patient's cavity at this time and the inflow stopcock was closed.There was a patient perforation, which occurred before the deficit increased as noted above.They completed a manual count and determined the true deficit was 800 ml.No additional information available.
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