OMNI EDGE SURGICAL SYSTEM

Description of Event or Problem

THE PHYSICIAN WHO PERFORMED AN OMNI SURGERY REPORTED THAT THE CATHETER DETACHED FROM THE CANNULA ENTIRELY. THE CATHETER WAS REMOVED FROM THE EYE USING FORCEPS AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY HAD BEEN REPORTED AND NO OTHER DEVICE WAS USED.

Additional Manufacturer Narrative

THE RETURNED DEVICE WAS CAREFULLY EVALUATED AND WAS DETERMINED THAT THERE IS NO EVIDENCE THAT THE DEVICE DESIGN OR MANUFACTURING PROCESS WAS THE CAUSE OF THE INCIDENT. A REVIEW OF DEVICE LOT HISTORY AND ANALYSIS OF THE MOST SUSPECTED COMPONENTS (I.E., CANNULA AND CATHETER) CONCLUDED THAT THERE WERE NO PRODUCTION NON-CONFORMANCES OR ANY OTHER ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ENGINEERING HAD PREVIOUSLY RECREATED THE SEVERING OF CATHETER FAILURE WHICH DID NOT POINT TO A DESIGN OR MANUFACTURING ISSUE AS THE CAUSE OF THE FAILURE. THE MODE OF FAILURE DOES SUGGEST IT'S ASSOCIATED WITH A USE ERROR. THE IFU PROVIDES CAUTIONARY STATEMENTS RELATED TO POSSIBLE KINKING OR DAMAGING (E.G., SEVERING) OF MICROCATHETER SHOULD THE STEPS NOT BE CORRECTLY PERFORMED. THEREFORE, IT IS CONCLUDED THAT THE PROBABLE ROOT CAUSE FOR THIS EVENT IS LIKELY DUE TO A SURGICAL TECHNIQUE OR USE ERROR.