The referenced device was not returned to the manufacturer.The exact cause of the reported event could not be conclusively determined.The oem conducted a dhr review for the concerned lot number.The device was manufactured in july 2014.The manufacturing and quality control reviews were performed and indicated there were no deviations during production.However, based on similar reported events the most probable cause can be attributed to improper handling, excessive stress by application of external bending and/or tensile forces by the user in combination with exceeded service life.As a preventive measure, the instruction manual¿s inspection and testing section provides warning and caution which states, - the cable has a restricted service life.- do not use the hf cable after one year of use.- visually inspect the cable and the plugs for irregularities on the surface and- do not use a cable with brittle or defective insulation.
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The manufacturer was informed that during a transurethral resection of the prostate (turp) procedure, the monopolar cable sparked and a flame was observed near the base of the plug that connects to the generator, esg-400.The esg-400 generator had a 140watt cut and 80watt coag setting.The esg-400 did not malfunction as it was completely checked and cleared by the clinical engineering.The procedure was not prolonged.Only the cable was replaced to complete the intended procedure.There was no patient or user injury reported.
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