The device manufacturer date is not known.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: foreign body lodged in the abdominal cavity probable root cause: 1.Material/design error, 2.Manufacturing/assembly/ service error, 3.Excessive user force, 4.Severe shipping conditions, 5.Disposable tip rubbing against product, 6.User error.The reported failure mode will be monitored for future reoccurrence.
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