RAPTOR

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH MW5165926 THAT, "STASIS DISPOSABLE RAPTOR GRASPING DEVICE NEEDED FOR A CASE. PACKAGE OPENED AND UPON REVIEW, THE CLEAVER DID NOT WORK. NOT SURE IF BROKEN. DEVICE NOT USED AND ANOTHER RAPTOR GRASPING DEVICE TAKEN OFF SHELF AND FUNCTIONING AND THEN USED IN PATIENT CASE." NO REPORT OF INJURY.

Additional Manufacturer Narrative

THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT WAS REQUESTED FOR RETURN AND EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUBJECT LOT AND NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. STERIS EVALUATED THE REPORTED EVENT AND DETERMINED IT DOES NOT MEET OUR REPORTING CRITERIA UNDER 21 CFR PART 803. IT SHOULD BE NOTED THAT STERIS IS SUBMITTING AN MDR SOLELY DUE TO THE RECEIPT OF THE USER FACILITY MEDWATCH REPORT WHICH IS IN ACCORDANCE WITH OUR POLICIES AND PROCEDURES. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

STERIS REQUESTED THE DEVICE FOR RETURN AND EVALUATION; HOWEVER, THE RAPTOR GRASPING DEVICE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED. WITHOUT THE RETURN AND EVALUATION OF THE DEVICE A CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.