RAPTOR

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED TO STERIS FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, A CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE RAPTOR GRASPING DEVICE INSTRUCTIONS FOR USE STATES, "THE DEVICE WAS DESIGNED FOR THE REMOVAL OF TEMPORARY STENTS. ACTUATE THE DEVICE BY MOVING THE SLIDER ON THE HANDLE BACK AND FORTH TO CONFIRM THAT THE GRASPING JAWS OPEN AND CLOSE SMOOTHLY. IF THE UNIT DOES NOT FUNCTION PROPERLY, OR THERE IS EVIDENCE OF DAMAGE (E.G. BENDS, KINKS, MISSHAPEN JAWS, MISALIGNED JAWS, EXPOSED WIRES) DO NOT USE THIS PRODUCT AND CONTACT YOUR LOCAL PRODUCT SPECIALIST. DO NOT USE EXCESSIVE FORCE ON THE HANDLE AND DO NOT COIL THE CATHETER OUTSIDE OF THE ENDOSCOPE. EXCESSIVE FORCE OR COILING MAY DAMAGE THE DEVICE OR DAMAGE THE ENDOSCOPE AND MAY RESULT IN ACCIDENTAL INJURY TO THE PATIENT OR CLINICIAN. THE FOLLOWING CONDITIONS MAY CAUSE THE DEVICE TO FUNCTION IMPROPERLY: ADVANCING THE HANDLE TO THE OPEN POSITION WITH TOO MUCH SPEED OR FORCE. ATTEMPTING TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE. ATTEMPTING TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION. ACTUATING THE DEVICE WHEN THE HANDLE IS AT AN ACUTE ANGLE IN RELATION TO THE SHEATH." THE DEVICE HISTORY RECORD FOR THE LOT SUBJECT OF THE REPORTED EVENT WAS REVIEWED; NO ABNORMALITIES WERE NOTED. STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE RAPTOR GRASPING DEVICE, AND THE USER FACILITY ACCEPTED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE IN-SERVICE IS COMPLETED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE RAPTOR GRASPING DEVICE LOCKED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE FOLLOWING A SHORT DELAY. NO REPORT OF INJURY.