RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THIS EVENT HAS NOT BEEN RETURNED TO STERIS ENDOSCOPY FOR EVALUATION; HOWEVER, THE DISTRIBUTOR HAS PROVIDED PHOTOGRAPHS OF THE DEVICE AND A VIDEO OF THE DEVICE BEING ACTUATED. CONTRARY TO THE INITIAL REPORT, EXAMINATION OF PHOTOGRAPHS AND VIDEO OF DEVICE ACTUATION HAS FOUND NO EVIDENCE OF DAMAGE OR MALFUNCTION. 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. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING STATEMENTS: "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." STERIS ENDOSCOPY HAS REQUESTED THAT THE DISTRIBUTOR OFFER IN-SERVICE TRAINING TO THE USER FACILITY. NO FURTHER ISSUES HAVE BEEN REPORTED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT A RAPTOR GRASPING DEVICE WAS DAMAGED PRIOR TO USE AND COULD NOT BE CLOSED. THE DEVICE WAS NOT USED IN A PROCEDURE NOR INSERTED INTO THE ENDOSCOPE. THE PATIENT HAD NO CONTACT WITH THE DEVICE AND THERE WAS NO HARM TO THE PATIENT OR USER.