UNIVERSAL FLAT PANEL YOKE, NO CABLES, LANDSCAPE

Description of Event or Problem

IT WAS REPORTED THAT WITHIN OPERATING ROOM #(B) (6), THE MONITOR #1 YOKE IS MISSING THE M3 SCREW. THE ISSUE WAS FOUND PRIOR TO CASES AND NO PTS WERE PRESENT. NO ADVERSE CONSEQUENCES OCCURRED AS A RESULT OF THIS MALFUNCTION.

Additional Manufacturer Narrative

THERE IS NO ESTABLISHED EXPIRATION DATE FOR THE MENTIONED DEVICE. DEVICE MANUFACTURED DATE IS UNK AT THIS POINT. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFO. EVALUATION SUMMARY - THE SAID DEVICE WAS EVALUATED IN THE FIELD. WHEN THE STRYKER ENGINEERS INSPECTED THE SINGLE FLAT PANEL SUSPENSION, THEY NOTICED THAT THE M3 SCREW WAS MISSING ON THE SAFETY SEGMENT FOR THE MONITOR. THIS CAN POTENTIALLY LEAD TO AN ADVERSE EVENT IF SEVERAL CASCADING EVENTS OCCUR. THE SAFETY SLEEVE WOULD HAVE TO SLIDE UP THE COLLAR OF THE SUSPENSION AND THEN THE SAFETY CLIP WOULD HAVE TO FALL OUT. IF THIS TOOK PLACE, THE MONITOR COULD FALL SLIGHTLY, BUT THE CABLES TO THE MONITOR WOULD LIKELY HOLD THE MONITOR UP. THE CAUSE OF THE M3 SCREW MISSING IS UNK AT THIS POINT. FURTHER INVESTIGATION IS ONGOING. THIS IS NOT A SINGLE-USE DEVICE.