RAPTOR

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO STERIS FOR EVALUATION. A QUALITY SYSTEMS SPECIALIST TESTED THE DEVICE AND FOUND THAT THE JAWS WOULD NOT OPEN WHEN ACTUATING THE HANDLE. THE QUALITY SYSTEMS SPECIALIST OPENED THE JAWS MANUALLY BY HAND AND THEN THE JAWS WERE ABLE TO OPEN AND CLOSE WITH THE HANDLE AS EXPECTED. AN EXACT CAUSE COULD NOT BE DETERMINED. IT IS UNKNOWN IF THE USER FACILITY TESTED THAT THE DEVICE FOR PROPER OPERATION PRIOR TO USE AS INDICATED IN THE INSTRUCTIONS FOR USE. THE RAPTOR GRASPING DEVICE - MINI INSTRUCTIONS FOR USE STATES, "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, AND ACTUATING THE DEVICE WHEN THE HANDLE IS AT AN ACUTE ANGLE IN RELATION TO THE SHEATH. DO NOT USE IF THE DEVICE IS DAMAGED OR IF THE STERILE BARRIER HAS BEEN COMPROMISED. SAVE THE DEVICE AND PACKAGING AND CONTACT YOUR LOCAL STERIS ENDOSCOPY PRODUCT SPECIALIST. PRIOR TO USE: 4. VISUALLY INSPECT THE DEVICE FOR DAMAGE. 6. 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." THE DEVICE HISTORY RECORD FOR THE SUBJECT LOT WAS REVIEWED AND CONFIRMED THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A REVIEW OF THE COMPLAINT LOG CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDSUN REPORT #(B)(4) THAT DURING A PATIENT PROCEDURE THEIR RAPTOR GRASPING DEVICE - MINI DID NOT OPEN ONCE IN THE PATIENT'S AIRWAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO REPORT OF INJURY OR PROCEDURE DELAY.