VISTEC

Additional Manufacturer Narrative

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 DEVICE(S) RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED PRODUCT(S) COULD NOT BE EVALUATED TO CONFIRM THE REPORTED FAILURE MODE. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

Description of Event or Problem

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

Additional Manufacturer Narrative

THE FOLLOWING SECTIONS WERE CORRECTED: D4 MANUFACTURING NAME; D4 UNIQUE IDENTIFIER (UDI) #. THE FOLLOWING SECTION WAS ANSWERED: G4 PMA/510(K)NUMBER.