The customer reported to olympus that during a therapeutic trans-urethral resection in saline (turis) urological procedure, the hf bipolar cable, while being used with the esg-400/hf generator displayed error message e006.A spark appeared near the break stop of the hf bipolar cable, causing the wire to break.The opinion from the doctor in charge stated that the damage was caused by continued output with the a cord disconnected.High-frequency output settings were 200w for electrolyte solution cut and 120w for electrolyte solution cut.There was no reported damage or effect on the patient or the hospital staff.The intended procedure was completed with a similar device.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to age-related wear and tear in combination with improper handling by the user like application of mechanical force, stress, bending and pulling.The event can be detected/prevented by following the instructions for use which state: "the service life of the cable is limited to 12 months.After this time, the cable should no longer be used.Furthermore, the cable must be checked for a damage prior to each use and after reprocessing.By gently pulling on the plug (with a maximum of 20 n) the user can determine if there is pre-existing damage to the stranded copper wire of the cable.If the cable does not buckle but remains firm, the cable is most likely fine in this place.Finally, in order not to increase the service life of the cable, the cable should not be wound up with a loop diameter of less than 10 cm, and the user should pull on the connector and not on the cable when unplugging the cable." olympus will continue to monitor field performance for this device.
|