RAPTOR GRASPING DEVICE - MINI

Additional Manufacturer Narrative

STERIS BECAME AWARE OF THIS EVENT ON DECEMBER 18, 2023 THROUGH OUR PERIODIC REVIEW OF THE MAUDE DATABASE. UPON REVIEW OF THE MAUDE REPORT THERE WAS NO CUSTOMER CONTACT INFORMATION. WITHOUT CUSTOMER CONTACT INFORMATION ADDITIONAL INFORMATION COULD NOT BE OBTAINED AND THE DEVICE COULD NOT BE REQUESTED FOR RETURN. WITHOUT THE RETURN OF THE COMPLAINT DEVICE, THE EXACT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES, "READ THE ENTIRE INSTRUCTIONS FOR USE AND FAMILIARIZE YOURSELF WITH THE DEVICE. OPEN THE PACKAGE AND REMOVE THE DEVICE. REMOVE THE PROTECTOR FROM THE DEVICE'S DISTAL END AND UNCOIL THE ENTIRE DEVICE. VISUALLY INSPECT THE DEVICE FOR DAMAGE. DRAPE THE CATHETER IN A "U" SHAPED CONFIGURATION. 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 COMPLAINT LOG WAS REVIEWED, AND THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT OF PRODUCTS. THIS IS CONSIDERED AN ISOLATED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA USER FACILITY MAUDE REPORT THAT DURING A PATIENT PROCEDURE THEIR RAPTOR GRASPING DEVICE MINI WOULD NOT OPEN AT THE JAW WHILE BEING PLACED THROUGH THE PATIENT'S AIRWAY TO MOVE A STENT. THE USER TRIED TO OPEN THE DEVICE OUTSIDE OF THE PATIENT BUT WAS UNSUCCESSFUL. NO REPORT OF INJURY.