RAPTOR

Additional Manufacturer Narrative

FOLLOWING THE SUBMISSION OF REPORT 1528319-2024-00083, STERIS WAS ABLE TO OBTAIN ADDITIONAL EVENT INFORMATION REGARDING THE REPORTED EVENT. A STERIS TERRITORY MANAGER DISCUSSED THE REPORTED EVENT WITH USER FACILITY PERSONNEL WHO STATED THAT THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT DID NOT OPEN FULLY DURING THE PATIENT PROCEDURE. USER FACILITY PERSONNEL UTILIZED ANOTHER RAPTOR GRASPING DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY. THE RAPTOR GRASPING DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. 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.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT THEIR RAPTOR GRASPING DEVICE WAS DEFECTIVE/NOT FUNCTIONING PROPERLY DURING A STENT REMOVAL. NO REPORT OF INJURY.

Additional Manufacturer Narrative

STERIS HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, THE USER FACILITY HAS NOT RESPONDED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND CONFIRMED THE SUBJECT LOT WAS MANUFACTURED TO SPECIFICATIONS; NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE REPORTED EVENT TO BE ISOLATED FOR THE SUBJECT LOT. THE RAPTOR GRASPING DEVICE INSTRUCTIONS FOR USE STATES, "THE DEVICE WAS DESIGNED FOR THE REMOVAL OF TEMPORARY STENTS. 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.". A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.