MEDLINE ANTI-FOG (EU), STERILE

Additional Manufacturer Narrative

WE ARE IN PROCESS OF TRYING TO GET THE DEVICE RETURNED FOR EVALUATION, AND THE INVESTIGATION IS ONGOING. ONCE WE HAVE ADDITIONAL RELEVANT INFORMATION, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "PRODUCT APPEARS TO BE LESS EFFECTIVE, RESULTING IN BLURRED IMAGES DURING LAPAROSCOPIC PROCEDURES. THIS PROBLEM HAS OCCURRED TWICE."

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AND NO PICTURES WERE PROVIDED, RESULTING IN THE COMPLAINT NOT BEING ABLE TO BE CONFIRMED. THE FOG SOLUTION FROM LOT 453252 UNDERWENT A FUNCTIONAL TEST PRIOR TO SHIPPING, AND IT PASSED AND WAS WITHIN SPECIFICATION. NO ROOT CAUSE COULD BE DETERMINED DUE TO NOT HAVING SAMPLES TO RETEST. HOWEVER, THE MOST PROBABLE ROOT CAUSE FOR SUCH AN EVENT WOULD BE FROM ENVIRONMENTAL TEMPERATURE CHANGES DURING TRANSIT OF THE FOG SOLUTION TO THE CUSTOMER AS THAT COULD CAUSE THE SOLUTION TO BE LESS EFFECTIVE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.