RAPTOR GRASPING DEVICE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE ONE JAW OF THEIR RAPTOR GRASPING DEVICE BECAME STUCK TO THE AXIOS STENT AND DID NOT FUNCTION PROPERLY. THERE WAS NO REPORT OF PROCEDURE DELAY OR INJURY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICE WAS RETURNED FOR EVALUATION AND FOUND TO BE DAMAGED. FURTHER REVIEW FOUND THAT THE HANDLE ASSEMBLY WAS CUT OFF SO THE FUNCTION OF THE DEVICE COULD NOT BE TESTED. ADDITIONALLY, IT WAS NOTED THAT THE CONTROL WIRES WERE DISCONNECTED FROM THE JAWS WHICH COULD INDICATE EXCESSIVE FORCE TO THE DEVICE. THE INSTRUCTIONS FOR USE PACKET (IFU 731747) LISTS WARNINGS AND PRECAUTIONS WHEN USING THE RAPTOR GRASPING DEVICE, "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 (DHR) WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED TO THIS LOT. A STERIS PRODUCT SPECIALIST OFFERED IN-SERVICE TRAINING ON THE PROPER USE OF THE DEVICE AND THE CUSTOMER HAS ACCEPTED. NO ADDITIONAL ISSUES REPORTED.