As per a manufacturer incident report we received from the factory in (b)(6): on (b)(6) 2021, during a surgical intervention, the bipolar resection loop again separated at the level of the yellow fixation systems.The material is lost between the bladder and the urethra with risks of perforation.
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Upon investigation, it could be confirmed that the loop was bent.Also, at the breaking point of the loop, it can be seen that the wire has melted; this could potentially have been caused by a short circuit when the electrode came too close to the neutral electrode during use.The root cause is most likely due to mechanical overload, i.E.User error.No indication for material or manufacture defect found during investigation.Ifu already included a warning that a mechanical overload can provoke a potential risk for the patient.
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