The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.However, since no device was returned, the exact cause of the reported issue could not be conclusively determined.Based on the lot number, the suspect device was manufactured in 2010; therefore, it is likely that the cable was used for longer than the specified 12 months.The cause of the damage is potentially due to age-related wear in connection with improper handling.The error described is a known error pattern and can be confirmed that age-related wear in connection with repeated extreme bending or tensile loads let to the breakage of single or all wires internally which can cause a voltage spike at the damaged area when the generator is activated which may result in a spark.In general the customer is required to check the function of all devices used prior to a procedure.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states, a suitable replacement device must be provided during an application.Additionally, the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Also, the cable must be checked for damage before each use and after reprocessing.By gently pulling on the plug (max.20nm), it can be determined whether the copper strand of the cable is already damaged.If the cable does not give way but remains rigid, the cable is most likely intact.In order not to shorten the service life of the cable any further, the cable should not be wound up with a loop diameter of less than 10cm and when pulling out the cable, the plug should be pulled and not the cable.Olympus will continue to monitor complaints for this device.
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