The reported event could be confirmed, since the device was returned and matches the alleged failure.We received the tissue protection sleeve for the inspection which revealed several scratches at the sleeve surface and material accumulation.The handle of the sleeve is broken which can be from forceful extraction.A functional inspection was performed with a sample adjusting device in which sleeve movement was as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation root cause can be attributed to user-related.If any additional information is provided, the investigation will be reassessed.
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