GIA PREMIUM

Description of Event or Problem

ACCORDING TO THE REPORTER DURING A HEMICOLECTOMY PROCEDURE, SURGEON FELT IT WAS HARD TO FIRE. HE ALSO STATED THAT THE CARTRIDGE LOOKED AS THOUGH IT WAS ALREADY PARTIALLY FIRED. THE OTHER CARTRIDGE FROM THIS PROCEDURE DID NOT FORM A GOOD STAPLE LINE AND HE FELT THE STAPLE LINE "FELL APART." ANOTHER CARTRIDGE WAS OPENED AND PLACED IN THE UNIT TO RESOLVE THE ISSUE. THE DEVICE PARTIALLY FIRED AND HAD AN INCOMPLETE STAPLE LINE. THE STAPLE LINE WAS RESECTED AND RESTAPLED. THE DIFFICULTY DID NOT RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION ETC. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO IRREVERSIBLE TISSUE DAMAGE. THERE WAS NO UNANTICIPATED EXTENSION OF THE INCISION BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENT'S CAVITY. THERE WAS NO DEVICE FRAGMENT LEFT IN PATIENT'S CAVITY.

Additional Manufacturer Narrative

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

POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE EVENT REPORT ALLEGES THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. THE VISUAL INSPECTION NOTED THAT THE RELOAD WAS RECEIVED PARTIALLY FIRED. MICROSCOPIC INSPECTION NOTED NO DAMAGE TO THE KNIFE BLADE. PUSHERS ADVANCED WITHOUT ANY DIFFICULTY, TEST MEDIA CLEANLY CUT AND ALL AVAILABLE STAPLES WERE PLACED WITH ACCEPTABLE FORMATION. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR IF THE FIRING STROKE IS NOT COMPLETE AND THE FIRING KNOB IS NOT FULLY RETRACTED AFTER FIRING OR IF THE INSTRUMENT IS APPLIED AGAINST AN EXCESSIVE AMOUNT OF TISSUE DURING THE CLINICAL APPLICATION. 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.