This supplemental report is being submitted to update the device available for evaluation, provide the date received by manufacturer, update device evaluated by manufacturer, provide the device manufacture date, update the event problem and evaluation codes, and provide the device investigational results.The device referenced in this report was returned for evaluation.Engineering investigated the issue and found that there was no visible damage at articulation sleeve area.The system error 31 was reproduced during system test.The inter-connectivity test failed at thermistor net.Through destructive analysis, it was found a thermistor+ traces crack and open on gastro flex #7 soldering area which could lead to system error 31 (temperature/thermal).Electrical open was confirmed by multimeter test.The possible root cause was determined as gastro flex thermistor trace crack and open because of insufficient cable assembly and/or gastro flex reliability which is related to design.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.
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