FLYTE HOOD

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS 4 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS 4 DEVICES WERE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION 4 DEVICES WERE LABELED FOR SINGLE-USE. 4 DEVICES WERE NOT REPROCESSED OR REUSED.

Description of Event or Problem

THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 4 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.