RAPTOR

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION. THE EVALUATION FOUND NO ISSUE WITH THE FUNCTION OR OPERATION OF THE DEVICE; THE REPORTED EVENT COULD NOT BE DUPLICATED. THE RAPTOR GRASPING DEVICE INSTRUCTIONS FOR USE STATES, "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 IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE RAPTOR GRASPING DEVICE; HOWEVER, THE USER FACILITY DECLINED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT AND CONFIRMED THE LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. THE COMPLAINT LOG WAS REVIEWED, AND THIS IS THE ONLY REPORTED COMPLAINT FOR THIS LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT THE JAWS TO THEIR RAPTOR GRASPING DEVICE WOULD NOT MOVE TO THE CLOSED POSITION DURING THEIR PRE-PROCEDURE CHECK. THE PROCEDURE WAS COMPLETED WITHOUT DELAY UTILIZING ANOTHER DEVICE. NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT IS BEING RETURNED FOR EVALUATION. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.