RAPTOR

Additional Manufacturer Narrative

THE DEVICES SUBJECT OF THE EVENT WERE DISCARDED BY USER FACILITY PERSONNEL PRIOR TO BEING RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICES, A ROOT CAUSE COULD NOT BE DETERMINED. UPON FURTHER INVESTIGATION, STERIS ENDOSCOPY LEARNED THAT USER FACILITY PERSONNEL DID NOT DO A PRE-PROCEDURE CHECK OF THE DEVICES AS STATED PER THE RAPTOR GRASPING DEVICE INSTRUCTIONS FOR USE, "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." A STERIS ACCOUNT MANAGER 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. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN, THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THAT THE JAWS TO TWO OF THEIR RAPTOR GRASPING DEVICES WERE NOT OPENING PROPERLY AND RESULTED IN A SHORT PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED USING A THIRD RAPTOR GRASPING DEVICE. NO REPORT OF INJURY.