ENDO DISSECT* 5MM INSTRUMENT

Additional Manufacturer Narrative

(B)(4). DEVICE HAS NOT BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SENT IF DEVICE IS RECEIVED.

Description of Event or Problem

ACCORDING TO THE REPORTER, THE TIP OF THE DEVICE WAS NOT ALIGNED. THIS WAS FOUND PRIOR TO THE PROCEDURE. THE DEVICE WAS NOT USED. THE PATIENT STATUS IS FINE. ADDITIONAL TISSUE RESECTION WAS NOT REQUIRED. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. NO BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS NOT EXTENDED. THE PATIENT GENDER IS NOT AVAILABLE. THE PATIENT AGE IS NOT AVAILABLE. THE PATIENT WEIGHT IS NOT AVAILABLE. THE DEVICE WAS NOT REPROCESSED/RE-STERILIZED PRIOR TO USE.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS NOT USED IN A SURGICAL PROCEDURE. VISUAL OBSERVATION AND MEASUREMENT INDICATED THE JAW ALIGNMENT WAS IN SPECIFICATION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.