CENTRA

Additional Manufacturer Narrative

THE STERIS TERRITORY MANAGER STATED THAT DURING FOLLOW-UP WITH USER FACILITY PERSONNEL, THE CENTRA BIOPSY FORCEPS WERE CONFIRMED TO BE OPERATING PROPERLY DURING PRE-PROCEDURE CHECKS. THE INSTRUCTIONS FOR USE STATES, "THE WHOLE DEVICE SHOULD BE CHECKED WHETHER THERE IS ANY DAMAGE (I.E. BEND OF CONNECTION PART AND INFLEXIBLE OPENING AND CLOSING OF FORCEPS) BEFORE USING THIS PRODUCT. IF THE PROBLEM EXISTS, PLEASE DO NOT USE." THE CENTRA BIOPSY FORCEPS SUBJECT OF THE REPORTED EVENT WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN OR EVALUATION. WITHOUT THE RETURN AND EVALUATION OF THE DEVICE THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. STERIS PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE CENTRA BIOPSY FORCEPS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE FOR QUADRANT SAMPLING, THEIR CENTRA BIOPSY FORCEP WAS "STUCK" IN AN OPEN POSITION. USER FACILITY PERSONNEL UTILIZED ANOTHER DEVICE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.