RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

THE REPORTED EVENT OCCURRED IN (B)(6) 2020; HOWEVER, STERIS WAS NOT NOTIFIED OF THE EVENT UNTIL RECEIPT OF THIS MEDWATCH ON (B)(6) 2021. STERIS ENDOSCOPY CONTACTED THE USER FACILITY UPON RECEIPT OF THE USER FACILITY MEDWATCH. THE CUSTOMER COULD NOT CONFIRM IF THE DEVICE HAD DAMAGE PRIOR TO USE OR IF THE DEVICE WAS FUNCTIONING AS EXPECTED DURING THE PRE-PROCEDURE INSPECTION. THE DEVICE WAS NOT RETURNED TO STERIS ENDOSCOPY FOR EVALUATION. 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." STERIS OFFERED AN IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE RAPTOR GRASPING DEVICE, HOWEVER THE USER FACILITY DECLINED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT #(B)(4) THAT DURING A PATIENT PROCEDURE FOR REMOVAL OF A FOREIGN BODY FROM THE DISTAL COLON, PART OF THE JAW OF THE RAPTOR GRASPING DEVICE BROKE AND DETACHED. THE RETRIEVAL OF THE FOREIGN BODY AND RAPTOR COMPONENT WAS SUCCESSFULLY COMPLETED. NO REPORT OF INJURY.