RAPTOR GRASPING DEVICE

Additional Manufacturer Narrative

STERIS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE DISTRIBUTOR HOWEVER, THE DISTRIBUTOR COULD NOT PROVIDE ADDITIONAL INFORMATION FROM THE END USER. STERIS REQUESTED THE SUBJECT DEVICE BE RETURNED FOR EVALUATION. TO DATE, STERIS HAS NOT RECEIVED THE DEVICE. WITHOUT THE RETURN AND EVALUATION OF THE DEVICE, A ROOT CAUSE CANNOT 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 THIS TO BE AN ISOLATED EVENT FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE DISTRIBUTOR REPORTED THAT DURING A PATIENT PROCEDURE, THE USER FACILITY'S RAPTOR GRASPING DEVICE WOULD NOT CLOSE AND WAS REMOVED IN THE OPEN POSITION. NO REPORT OF INJURY.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.