The product was discarded on site and could not be recovered.The device history record review was not able to be performed since the lot number is unknown.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action was deemed necessary.No product is available for evaluation, therefore the investigation into the root cause was unable to be performed, and the root cause was determined to be inconclusive.There was no patient impact or injury.The investigation is complete.See related 0001920664-2021-00012 ¿ second cutter and 0001920664-2021-00013 ¿ third cutter.
|