ENDO DISSECT

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

THE ISSUES WITH BOTH DEVICES OCCURRED PRIOR TO A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE DURING PREPARATION. FOR THE DISSECTING DEVICE, THE DISTAL JAW TIPS ARE A LITTLE TWISTED. FOR THE CLINCHING DEVICE, THE LATCHET FUNCTION DOES NOT WORK. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, REPLACED WITH NEW DEVICES. THERE WAS NO PATIENT HARM. THE PATIENT STATUS IS ALIVE, NO INJURY.

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

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE JAWS WERE WITHIN THE STANDARD MANUFACTURING SOP OF 0.020¿ AND DO NOT AFFECT THE FUNCTIONAL USE OF THE PRODUCT. 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.

Additional Manufacturer Narrative

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