RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

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 CONFIRMED THE DEVICE LOT WAS MANUFACTURED TO SPECIFICATION. THE USER FACILITY RECEIVED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE DEVICE. STERIS REQUESTED THE RAPTOR GRASPING DEVICES BE RETURNED FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE THEIR RAPTOR GRASPING DEVICE WOULD NOT CLOSE. USER FACILITY PERSONNEL UTILIZED AN ADDITIONAL RAPTOR GRASPING DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURY OR PROCEDURE DELAYS WERE REPORTED.

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICES SUBJECT OF THE REPORTED EVENT WERE RETURNED FOR EVALUATION. EVALUATION RESULTS DETERMINED THAT KINKS WERE FOUND FROM THE DISTAL POINT WHICH INDICATES THE USER ATTEMPTED TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE OR ATTEMPTED TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION. THE USER FACILITY RECEIVED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE DEVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.