This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: smoke came out of the column, we could not identify from which material.Probable root cause: product shorts and generates a small puff of smoke outside of surgery.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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