Product complaint # (b)(4).Visual inspection of the returned device found the ball tip feeler shaft was bent.The ball tip was broken, and not returned to the manufacturer.No other issues were identified with the returned components of the device.A cursory inspection of the complaint file for the device that was found damaged does not point to a manufacturing issue.Therefore a device history record is not required.A definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.
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