ENDO GRASP

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.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE JAWS WOULD NOT OPEN ENOUGH EVEN WHEN THE USER RELEASED THE RATCHET. THIS PROBLEM OCCURRED IN TWO OF THE SAME TYPE OF DEVICES. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE OR BLEEDING WAS CAUSED .THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.

Additional Manufacturer Narrative

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF TWO DEVICES. VISUAL FUNCTIONAL INDICATED NO ABNORMALITIES. 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. 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.