The resecting device was not returned for investigation.Physical product examination is not possible.Based on the description of hysteroscopic image and more specifically the "synechia" type tissue, it is likely that the symphion procedure was initiated and conducted in an unrecognized false passage, which ultimately led to a uterine perforation.Uterine perforations are known complications of polypectomy.Complications associated with uterine perforations are addressed in the warning section of the operator's manual and instructions for use, including the statements: use caution not to perforate the uterine wall when sounding, dilating, or inserting the resecting device.Excessive force applied during placement of the resecting device may result in tissue injury, including perforation.Clinical judgment must always be used.
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It was reported that a symphion polypectomy was performed by an ob/gyn resident.The case according to the report was challenging (details unknown).At the time of hysteroscope insertion, it was reported that the user saw (based on description) synechia type tissue and decided to "clean" the cavity.After about 5 minutes of "cleaning" a uterine perforation was suspected, based on sudden loss of fluid and visualization of the organs of the abdominal cavity.The case was aborted.
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