RAPTOR

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT # 4900420000-2026-8017 THAT DURING A PATIENT PROCEDURE "A RETAINED ESOPHAGEAL STENT IN THE TERMINAL ILEUM WAS ATTEMPTED FOR RETRIEVAL USING A STERIS RAPTOR GRASPING DEVICE, THE DEVICE MALFUNCTIONED AND BECAME EMBEDDED IN THE TERMINAL ILEUM DISTAL TO THE STENT. MULTIPLE ENDOSCOPIC MANEUVERS WERE PERFORMED TO DISENGAGE AND RETRIEVE THE DEVICE; HOWEVER, THESE WERE UNSUCCESSFUL. THE WIRES OF THE RAPTOR GRASPING DEVICE WERE CUT, THE SCOPE WAS READVANCED INTO THE TERMINAL ILEUM WHERE ADDITIONAL ATTEMPTS AT REMOVING THE DISTAL END OF THE RAPTOR WERE UNSUCCESSFUL." A PROCEDURE DELAY WAS REPORTED.

Additional Manufacturer Narrative

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, STERIS LEARNED THAT THE PATIENT HAS SINCE BEEN DISCHARGED. USER FACILITY PERSONNEL ALSO CONFIRMED THAT NO ISSUES WERE NOTED WITH THE SUBJECT DEVICE DURING PRE-PROCEDURE CHECKS. THE DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, A CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THE SUBJECT LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. THE INSTRUCTIONS FOR USE STATES, "THE DEVICE WAS DESIGNED FOR THE REMOVAL OF TEMPORARY STENTS. VISUALLY INSPECT THE DEVICE FOR DAMAGE. DRAPE THE CATHETER IN A "U" SHAPED CONFIGURATION. 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 FOR THE RAPTOR GRASPING DEVICE HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.