RAPTOR GRASPING DEVICE - MINI

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS SENT BACK FOR EVALUATION. EVALUATION RESULTS DETERMINED THAT WHEN THE RAPTOR GRASPING DEVICE HANDLE WAS ACTUATED THE JAWS WOULD NOT OPEN. FURTHER REVIEW DETERMINED THAT FOREIGN MATTER WAS PRESENT WHICH MAY HAVE CONTRIBUTED TO THE DEVICE NOT OPENING AND CLOSING PROPERLY. THE RAPTOR GRASPING DEVICE WAS DISASSEMBLED AND FOUND THAT NO ISSUES WERE NOTED WITH THE INTERNAL WIRES. 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." THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT THE USER TRIED TO USE THE RAPTOR GRASPING DEVICE HOWEVER, IT DID NOT FUNCTION PROPERLY. THE JAWS ON THE DEVICE WOULD NOT OPEN AND CLOSE AND WAS UNABLE TO GRASP OBJECTS. ANOTHER RAPTOR GRASPING DEVICE WAS UTILIZED, AND THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.