ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN

Description of Event or Problem

DURING A CHOLECYSTECTOMY PROCEDURE NO FUNCTION AFTER A FEW MINUTES. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO ADVERSE PT CONSEQUENCE. THERE IS NO FURTHER INFO AVAILABLE.

Additional Manufacturer Narrative

BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. THE DEVICE WAS TESTED WITH A GENERATOR AND AN ERROR CODE 5 WAS RECEIVED. THE IDENTIFIED BLADE DAMAGE MAY HAVE OCCURRED FROM EXTERNAL CONTACT DURING PRE-OP OR GENERAL USE. IN ADDITION, MINOR BLADE DAMAGE MAY INCREASE IN SEVERITY DURING SUBSEQUENT ACTIVATIONS, AND MAY RESULT IN BLADE "LOCKOUT" LATER IN THE PROCEDURE. THEREFORE, THE INSTRUCTIONAL INSERT STATES: "SCRATCHES ON THE BLADE MAY LEAD TO PREMATURE BLADE FAILURE" AND "AVOID ACCIDENTAL CONTACT WITH OTHER INSTRUMENTS DURING USE." THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS. 510(K) NUMBER IS K990362.