VISTEC

Description of Event or Problem

THE CUSTOMER REPORTED THAT RAY-TEC SPONGES WERE INSPECTED PRIOR TO USE AT THE OR GENERAL SURGERY. DURING INSPECTION, TWO RAY-TEC SPONGES FROM A PACKAGE OF TEN WERE FOUND TO HAVE FIBER SEPARATING AND SHEDDING. THE MANAGEMENT WAS NOTIFIED IMMEDIATELY UPON DISCOVERY. THE SURGICAL TEAM WAS MADE AWARE AND REMAINED VIGILANT THROUGHOUT THE PROCEDURE, REGULARLY CHECKING FOR ANY POTENTIAL FIBER SHEDDING TO ENSURE NO MATERIAL WAS RETAINED. THE ISSUE WAS NOTICED DURING PREPARATION AND BOTH AFFECTED RAY-TEC SPONGES WERE IMMEDIATELY REMOVED FROM THE STERILE BACK TABLE AND NOT USED ON THE PATIENT.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.