The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: subcutaneous emphysema swelling of the skin.Investigation conclusion- the reported incident could not be confirmed, since the device was not returned for evaluation.Probable root cause: most of the reasons for occurrence of a subcutaneous emphysema are related to surgical technique and trocar placement.Incorrect placement of a cannula, veress needle or a trocar into subcutaneous tissue may lead to emphysema, which can lead to crepitus.A big leakage of co2 around trocar incisions may also lead to subcutaneous emphysema.Other risk factors are prolonged surgeries, the use of many access points to the abdominal cavity and an elevated abdominal pressure.In addition, the event description does not include any indication for a device malfunction, nor is subcutaneous emphysema considered a serious injury.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known at this time.Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).
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