ANASTOCLIP GC CLOSURE SYSTEM - VASCULAR & NEURO

Description of Event or Problem

IT WAS REPORTED THAT DURING THE SURGERY, WHEN ATTEMPTING TO APPLY A CLIP TO THE DURA MATER, THE CLIP DID NOT CLOSE PROPERLY, PREVENTING CLOSURE OF THE DURA. A SUBSTITUTE DEVICE AVAILABLE AT THE HOSPITAL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO ADVERSE IMPACT ON THE PATIENT'S HEALTH WAS REPORTED.

Additional Manufacturer Narrative

WE DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED MALFUNCTION. PER THE IFU: "SQUEEZE THE LEVERS TOGETHER FULLY UNTIL A DISCERNIBLE CLICK IS FELT. FAILURE TO SQUEEZE THE LEVERS COMPLETELY CAN RESULT IN CLIP MALFORMATION AND POSSIBLE BLEEDING OR LEAKAGE. CHECK TIGHTNESS OF CLIP PLACEMENT. TISSUE SHOULD COMPLETELY FILL CLIP OPENING AND CLIP SHOULD NOT LOOSELY ROCK SIDE TO SIDE". THE PRODUCTION AND TRACEABILITY RECORD FOR THE DEVICE WAS REVIEWED; NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL QUALITY CONTROL TESTS WERE COMPLETED SUCCESSFULLY AND MET SPECIFICATION. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.