M220 F12

Additional Manufacturer Narrative

THIS IS A COMBINED INITIAL/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-(B)(4) 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.

Description of Event or Problem

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT M220 OPTICS CARRIER FELL DOWN WHEN PREPARING FOR THE NEXT SURGERY. THERE WAS NO PATIENT OR USER INJURY.