VISTEC

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED THAT A SCRUB TECH WAS COUNTING RAYTECS ADDED TO THE FIELD AND SAW THAT THEY WERE MISSING THE RADIOPAQUE THREADS IN TWO OF THE SPONGES. PHOTO ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 04JUN2026 STATED THAT THE PATIENT WAS AT THE FACILITY FOR A RIGHT PAROTIDECTOMY WITH NECK DISSECTION. DURING THE PROCEDURE, THE SCRUB TECH NOTICED 2 OF THE RAYTEC SPONGES WERE MISSING THE BLUE LINE X-RAY DETECTABLE MATERIALS (THEY LOOKED LIKE REGULAR 4 X 4S). NO 4 X 4S WERE OPENED ONTO THE STERILE FIELD. THE SCRUB TECH IMMEDIATELY LET THE CIRCULATING NURSE KNOW AND REMOVED THEM FROM THE STERILE FIELD. THEY WERE NEVER USED ON THE PATIENT, BUT WERE KEPT OFF THE FIELD TO BE INCLUDED IN THE ORIGINAL SURGICAL COUNT. THE REFERENCE NUMBER WAS (B)(4) AND THE LOT NUMBER WAS 25M032462. THE PROCEDURE WAS STILL ABLE TO CONTINUE AS SCHEDULED AND THERE WAS NO HARM TO THE PATIENT. ALL COUNTS WERE CORRECT FOR THE CASE.