ENDO GRASP

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, INTRAOPERATIVELY, WHEN THE DEVICE WAS PULLED OUT, THE JAW WAS CRACKED AND BROKEN. THE BALLOON LEAKED GAS OR AIR.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. SHEARING DAMAGE OF THE PLASTIC CABLE SHEATH WAS OBSERVED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHERE AN EXCESSIVE FORCE OR LEVERAGE IS APPLIED TO THE DEVICE WHILE RETRACTING THE CLEVIS ASSEMBLY AND THE CLEVIS BOOT IS SUBSEQUENTLY DAMAGED. THIS SUBSEQUENT DAMAGE MAY RESULT IN IMPROPER RETRACTION AND DEPLOYMENT OF THE JAWS DURING ARTICULATION AND MAY CAUSE SHEARING OF THE PLASTIC CABLE SHEATH. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.