VISTEC

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD A COUPLE OF RAYTECS OPENED (NOT IN PACKS) THAT WERE SHEDDING WHEN IN USE. THE SURGEON HAD TO IRRIGATE IT WAS SO BAD. THEY OPENED 2 OF THESE WITH THE SAME RESULTS. ON (B)(6) 2025 THE CUSTOMER STATED THAT THEY OPENED BOTH ON THE SAME CASE. THE RAYTECS WERE UNFOLDED WHEN USED THEN DISCARDED. IT WAS STATED THAT IRRIGATING PROFUSELY IS ALL THAT WAS DONE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR LOT 25A035062 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. 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. THERE WERE NO PHYSICAL SAMPLES RETURNED FOR EVALUATION. INSTEAD, PHOTOS WERE PROVIDED FOR REVIEW; THE REPORTED ISSUE WAS OBSERVED. HOWEVER, THE PHOTOS DID NOT SHOW THE FULL PRODUCT AND WE WERE UNABLE TO DETERMINE IF THE GAUZE WAS UNRAVELED CAUSING THE SELVAGE EDGES TO BE EXPOSED RESULTING IN SHEDDING. ADDITIONALLY, THERE WERE NO ISSUES IDENTIFIED AS PART OF THE IN-PROCESS INSPECTIONS. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED, AND NO CORRECTIVE AND PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.