Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on an unknown date, the surgeon was trying to straighten out the tip of the ball and the tip broke off.The fragment did not land in the patient, just on the surgical field.Procedure outcome is unknown.There was no patient consequence.This report is for a moss ball tip feeler straight.This is report 1 of 1 for (b)(4).
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