Root cause: the light handle cover is a component contained within a convenience kit.The cover is contract manufactured to a specification.Therefore, a supplier corrective action request was issued to the contract manufacturer.A potential root cause of a defective cover was identified; however, inspection data showed no evidence of a fit failure.Corrective action: in its scar response, the supplier stated it shall continue to follow procedures outlined for inspection frequency of the product fit.It will continue to monitor product during manufacturing utilizing inspection plan and go/no-go gauges that are required for the product.Investigation summary: an internal complaint (call 40762) was received indicating that a light handle cover contained within a finished good pack (part number 50-1895) fell off a surgical light during a procedure and was cracked.A sample was not returned for evaluation.A lot number was not provided, and due to the absence of a reported lot number, the work order could not be reviewed for discrepancies that may have contributed to the reported event.The raw material component was identified as 4-9542-1.This component is contract manufactured, and a supplier corrective action request was issued to the contract manufacturer.A response was received and accepted may 24, 2017.Deroyal will continue to monitor post market feedback and will recognize in the future if the reported issue recurs.Preventive action: in its scar response, the supplier referred to its above stated corrective action.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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