LEICA M220 F12

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. LEICA MICROSYSTEMS PERFORMED A ROOT CAUSE INVESTIGATION WHICH IDENTIFIED THE CAUSE OF THE OBSERVED PROBLEM AS INSUFFICIENT SECURING OF THE SCREW CONNECTING THE SWING ARM TO THE OPTICS CARRIER. IT WAS DETERMINED THAT THIS SCREW WAS NOT ADEQUATELY SECURED WITH THE APPROPRIATE AMOUNT OF HIGH STRENGTH THREAD ADHESIVE TO ENSURE A RELIABLE CONNECTION OF THE SWING ARM TO THE OPTICS CARRIER. THIS INSUFFICIENT SECURING OF THE SWING ARM WAS NOT IDENTIFIED DURING PRODUCTION AND FINAL INSPECTION OF THE M220 F12 SWING ARM. THESE SWING ARMS WERE THEN BUILT INTO THE M220 F12 SURGICAL MICROSCOPES MANUFACTURED BEFORE MARCH 9TH, 2017. AS A RESULT, THE SCREW THAT CONNECTS THE SWING ARM TO THE OPTICS CARRIER HAS LOOSENED OVER TIME AND CONSEQUENTLY CAUSED THE OPTICS CARRIER TO FALL DOWN. BASED ON THE RESULTS OF THE ROOT CAUSE INVESTIGATION, THE PROBABILITY OF THE END USER DETECTING THIS DEFECT IS VERY LOW. CAPA-HER-MD-21-002 AND THE ASSOCIATED FSCA (FDA RECALL #: Z-0412-2022; FDA RECALL ID: 89009) WERE INITIATED TO ADDRESS THIS ISSUE. THE DEFECTIVE SWING ARM WAS REPLACED BY A NEW ONE.

Additional Manufacturer Narrative

LEICA MICROSYSTEMS (B)(4) HAS PERFORMED A ROOT CAUSE INVESTIGATION WHICH REVEALED THAT THE FAILURE MODE IS RELATED TO A LOOSE SCREW IN THE SWING ARM OF THE LEICA M220 F12 WHICH IS HOLDING THE OPTICS CARRIER IN PLACE. TECHNICAL INVESTIGATION REVEALED THAT THERE WAS AN INSUFFICIENT AMOUNT OF HIGH STRENGTH THREAD ADHESIVE APPLIED TO THE SCREW. THE IDENTIFIED ROOT CAUSE IS A WEAKNESS IN THE PRODUCTION PROCESS INTENDED TO SECURE THE SCREW CONNECTING THE OPTICS CARRIER TO THE FREE END OF THE SWING ARM. THE PRODUCTION STEP TO APPLY HIGH STRENGTH THREAD ADHESIVE TO THE SCREW WAS MISSED FOR THIS DEVICE. THIS IS AN INITIAL REPORT. A DEEPER INVESTIGATION OF THE PRODUCTION PROCESS IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM (B)(6) STATING THAT THE M220 OPTICS CARRIER FELL DOWN DURING PREPARATION FOR A SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY. ANOTHER OPERATING MICROSCOPE WAS USED TO PERFORM THE OPERATION.