AQUA JET ROUTINE I TAPED CASS NO/LID

Additional Manufacturer Narrative

A DEVICE HISTORY REVIEW WAS COMPLETED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCE'S ASSOCIATED WITH THIS LOT. QUALITY CONTROL TESTING WAS COMPLETE AND PASSED. RETURNED CASSETTE AND METAL LID WERE TESTED. THE RETURNED METAL LID AND CASSETTE WERE TESTED DURING A STANDARD EIGHT (8) HOUR RUN IN THE LEICA PELORIS PROCESSOR. THE TESTING CONFIRMED THE LID DETACHED FROM THE CASSETTE. THE CUSTOMER COULD NOT IDENTIFY THE EXACT LOT NUMBER ASSIGNED TO THE RETURNED CASSETTE IN QUESTION. THEREFORE THREE LOT NUMBERS WERE PROVIDED THAT THE CUSTOMER WAS ABLE TO CONFIRM THE CASSETTE CAME FROM. A BOX OF EACH OF THE THREE CASSETTE LOT NUMBERS WERE RETURNED FROM THE CUSTOMER FOR ADDITIONAL TESTING. ALL CASSETTES PERFORMED AS INTENDED AND NONE DETACHED FROM THE LID IN THE LEICA PELORIS TISSUE PROCESSOR. RETAIN SAMPLES FOR THIS LOT NUMBER WERE AVAILABLE AND TESTED. ALL RETAIN CASSETTES PERFORMED AS INTENDED AND NONE DETACHED FROM THE LID IN THE LEICA PELORIS TISSUE PROCESSOR. THE SINGLE CASSETTE WAS IDENTIFIED AS AN ISOLATED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP MDR WILL BE SUBMITTED. THIS IS MDR NUMBER 3 OF 3 TO COVER THE THREE POTENTIAL LOT NUMBERS REPORTED BY THE CUSTOMER. THIS MDR IS FOR LOT NUMBER A16892438.

Description of Event or Problem

ON (B)(6) 2021 THE CUSTOMER EXPERIENCED ONE (1) CASSETTE OF THE AQUA JET ROUTINE I TAPED CASS NO/LID (P/N 38440010, LOT A16892438) WITH A METAL LID, WHICH HAD OPENED DURING PROCESSING CAUSING THE ENTIRE LYMPH NODE TO BE LOST.