RAPTOR GRASPING DEVICE

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT (MW5115832) THAT THEIR RAPTOR GRASPING DEVICE WORKED ON THE FIRST PASS BUT WOULD NOT OPEN DURING THE SECOND PASS. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THIS COMPLAINT WAS NOT RETURNED TO STERIS ENDOSCOPY FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE FOR EVALUATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE DEVICE LOT WAS MANUFACTURED TO SPECIFICATION. THERE HAVE BEEN NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT. STATEMENTS IN THE INSTRUCTIONS FOR USE INCLUDE: "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.". NO FURTHER ISSUES HAVE BEEN REPORTED.