Additional details received by richard wolf about the devices used: according to the sales rep, the settings used: power settings 80/80.That means 80 cut and 80 coag.Picture of the generator used during the procedure is attached and forwarded to rw gmbh for the device investigation.Investigation report: device evaluation from rw gmbh.The device was sent to rw gmbh for evaluation.Findings: "the devices were inspected in the responsible department.The received information about the used hf generator and the power settings without the information about the duration of the procedure and the used product combination is not sufficient enough to determinate the cause of the event further.Three electrodes 46782425 cutting electrodes mono 24fr 12/30 were received.All electrodes show damage to the distal insolation and two electrodes broke at the loop.In addition, all electrodes are severely bent and in two electrodes the reinforcing tube is displaced.The visible changes on the electrodes indicate mechanical and thermal-electrical overloads.However no definitive statement can be concluded based on the available information to what exactly caused this overload.The further deformations of the electrodes and the forward displaced reinforcing tube could have been caused by applying too much force during assembly or disassembly of the electrodes.As a result, the isolation may have been pre-damaged and further damaged during the use with hf current.Therefore, the user is advised in the relevant ifu ga-d366-usa rev.04 to carry out visual checks and to avoid strong use of force on the electrodes.In addition, the assembly and disassembly procedure is also described in details." the reported condition was confirmed.Probable root cause: user error.
|