VERION DIGITAL MARKER M

Additional Manufacturer Narrative

H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE SYSTEM WITH REGISTRATION FAILURE OCCURRED AND AN ERROR MESSAGE DISPLAYED IN THE UNKNOWN EYE OF A PATIENT, DURING SURGERY. THERE WAS NO PATIENT HARM.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE EVALUATION OF THE PROVIDED DATA BY THE PRODUCT MANUFACTURER'S SUBJECT MATTER EXPERT SHOWED THAT THE REPORTED ISSUE WAS CAUSED BY USER HANDLING AS THE REQUIREMENTS FOR AN APPROPRIATE SURGERY IMAGE WERE NOT MET, IMPACTING THE QUALITY OF THE CAPTURED IMAGE. THE ZOOM, CENTRATION AND PRESENCE OF THE SPECULUM IMPACTED THE IMAGE QUALITY, AND THEREFORE REGISTRATION FAILED. THE INVESTIGATION THEREFORE IS CONCLUDED BASED ON THIS ANALYSIS. THE ROOT CAUSE COULD BE DETERMINED AS USER HANDLING SINCE ESTABLISHED PROCEDURES TO ACHIEVE OPTIMAL IMAGE QUALITY WERE NOT FOLLOWED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).