RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE SUPPLIER FOR EVALUATION. FOLLOWING THE EVALUATION, THE SUPPLIER REPORTED THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE BROKEN JAW. THE SUPPLIER PERFORMS A VISUAL INSPECTION FOR CRACKS DURING FINAL INSPECTION. A REVIEW OF THEIR RECORDS FOR THE BATCH RELATED TO THIS EVENT INDICATES THERE WERE NO NONCONFORMANCES. STERIS REVIEWED OUR DEVICE HISTORY RECORD AND CONFIRMED THE DEVICES WERE MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. 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 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. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

STERIS HAS REQUESTED THE DEVICE TO BE RETURNED FOR EVALUATION. THE INVESTIGATION OF THE SUBJECT EVENT IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE UPON WITHDRAWAL OF THE RAPTOR GRASPING DEVICE, THE USER NOTED THAT PART OF JAW COMPONENT OF A RAPTOR GRASPING DEVICE HAD DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO REPORT OF HARM TO THE PATIENT.