RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, A ROOT CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE SUBJECT LOT WHICH CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE REPORTED EVENT TO BE ISOLATED FOR THE SUBJECT LOT. THE INSTRUCTIONS FOR USE STATES, "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." STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE RAPTOR GRASPING DEVICE AND IS AWAITING A RESPONSE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE WIRE ON THE RAPTOR GRASPING DEVICE "BROKE" WHILE REMOVING A FOOD BOLUS. ANOTHER RAPTOR GRASPING DEVICE WAS SUCCESSFULLY UTILIZED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A DELAY. NO REPORT OF INJURY.

Additional Manufacturer Narrative

STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE RAPTOR GRASPING DEVICE HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.