GIA PREMIUM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: EVALUATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THE RELOAD DISPLAYED A FULL COMPLEMENT OF STAPLES. DAMAGE WAS NOTED TO THE FIRING KNOB SIDE OF THE KNIFE BLADE CHANNEL. MICROSCOPIC INSPECTION REVEALED NO DAMAGE TO THE KNIFE BLADE. FUNCTIONAL TESTING WAS PRECLUDED DUE TO THE OBSERVED CONDITION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THIS CONDITION MAY OCCUR IF AN EXCESSIVE FORCE IS APPLIED TO THE KNIFE BLADE ASSEMBLY PRIOR TO FIRING. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLES DID NOT DEPLOY FOR THE RELOAD WAS EMPTY, IT WAS WITHOUT STAPLES. THE SURGEON USED ANOTHER RELOAD FOR THE END OF THE PROCEDURE. NO PATIENT INJURY.