VISTEC

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING THE PROCEDURE A PACK OF RAYTECS WERE OPENED ON THE SURGICAL FIELD AND COUNTED. SCRUB PERSONNEL NOTICED THERE WAS NOT AN RFID [RADIO-FREQUENCY IDENTIFICATION] SEWN INTO THE RAYTECS. RAYTECS WERE IMMEDIATELY REMOVED FROM THE FIELD AND ACCOUNTED FOR.

Additional Manufacturer Narrative

A NON-CONFORMANCE REVIEW WAS CONDUCTED FOR LOT 24J056162 AND THERE WERE NO NCS RELATED TO THE REPORTED EVENT ISSUED DURING THE MANUFACTURING OF THIS LOT. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THE REPORTED LOT PASSED ALL REQUIREMENTS. THERE WERE NO DEVICES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT COULD NOT BE EVALUATED TO OBSERVE THE REPORTED FAILURE.AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE ARE UNABLE TO ASSOCIATE THIS REPORTED ISSUE TO AN OPEN CAPA DUE TO NO PHOTO OR SAMPLE RECEIVED FOR EVALUATION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.