VISTEC

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY RECEIVED 9 INSTEAD OF 10 GAUZE.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED WITHIN THE COMPLAINT. 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 SAMPLES RETURNED FOR EVALUATION, THEREFORE THE AFFECTED DEVICE COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.