Method: actual device not evaluated.Result: no results available since no evaluation performed.Conclusion: failure to follow instructions.Asp investigation summary: the investigation included a review of the system risk analysis (sra).Without the lot number and product return, limited investigation could be performed.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." the most likely assignable cause for the reported event is handling of the cassette without use of personal protective equipment (ppe), as directed in the instructions for use (ifu) for this cassette.A customer letter was sent to remind the customer to use ppe.The cassette was not returned for evaluation.The issue will continue to be tracked and trended.
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