The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards one decontaminated sample without original package or lot number was received for evaluation.After performing a visual inspection based on our procedure, tip damage was observed.A gemba walk was performed at the manufacturing area with the multifunctional team (quality, manufacturing, engineering) and no deviation from the validated process has been found.After reviewing the reported sample clear evidence of its usage can be seen, suggesting that there was handling after the manufacturing process, therefore it cannot be confirmed if the issue originated before or after the manufacturing.The manufacturing personnel involved in the process were notified about the reported condition.The issue was not confirmed to be manufacturing related; the current manufacturing process has been reviewed and currently meets all quality and manufacturing specifications.No further actions are considered necessary at this time.
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