RAPTOR GRASPING DEVICE

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR RAPTOR GRASPING DEVICE PARTIALLY DETACHED INSIDE OF THE PATIENT DURING PROCEDURAL USE. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ONE DEVICE SUBJECT OF THE REPORTED EVENT WAS SENT BACK FOR EVALUATION. EVALUATION RESULTS DETERMINED THAT THERE WAS AS SIGNIFICANT BEND ABOUT FOUR INCHES FROM THE DISTAL END OF THE DEVICE. THIS BEND CAUSED THE DEVICE TO LOSE ITS STABILITY. THE BEND IS INDICATIVE OF THE USER FACILITY ATTEMPTING TO ACTUATE THE DEVICE IN AN EXTREMELY COILED POSITION OR ATTEMPTING TO PASS OR OPEN THE DEVICE IN AN EXTREMELY ARTICULATED ENDOSCOPE WHICH CAN CAUSE THE DEVICE TO MALFUNCTION. IN ADDITION TO THE BEND, IT WAS FOUND THAT THE CONTROL WIRES WERE DISCONNECTED FROM THE JAWS OF THE RAPTOR DEVICE. BASED ON THE REVIEW OF THE RETURNED DEVICE, IT WAS DETERMINED THE LIKELY CAUSE OF REPORTED ISSUE WAS CUSTOMER HANDLING. USER FACILITY PERSONNEL WERE OFFERED IN-SERVICE TRAINING ON THE PROPER USE OF THE RAPTOR; HOWEVER, THEY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.