ENDO DISSECT* 5MM INSTRUMENT

Additional Manufacturer Narrative

TRACKING NUMBER: (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, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS NOT ALIGNED. THE DEVICE WAS NOT USED. THE UDI NUMBER IS NOT AVAILABLE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE STATUS OF THE PATIENT 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

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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

(B)(4).