2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPE

Description of Event or Problem

LEFT FEM-POP BYPASS WITH INSERTION OF SAPHENOUS VEIN: "DISPOSABLE ANGIOSCOPE WOULD NOT DISPLAY PICTURE DURING SURGICAL PROCEDURE."

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVAL. UPON INSPECTION, ENGINEERING CONFIRMED THE DEVICE DISPLAYED A SKEWED AND BLURRY IMAGE. NO DAMAGE WAS NOTED TO THE UNIT. ENGINEERING DISASSEMBLED THE UNIT AND FOUND THAT ONE EYEPIECE LENS WAS OUT OF ITS PROPER POSITION. ALL ENDOSCOPES UNDERGO 100% VISUAL INSPECTION AND ARE FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS. IT IS LIKELY THAT THE LENS WAS NOT SECURED IN ITS PROPER POSITION DUE TO AN OPERATOR ERROR AND BECAME DETACHED INSIDE THE EYEPIECE DURING SHIPPING AND HANDLING OF THE PRODUCT. THE PRODUCTION TEAM HAS BEEN NOTIFIED OF THIS OCCURRENCE IN ORDER TO DEVELOP A HEIGHTENED AWARENESS OF THE INCIDENT. THIS DOCUMENT REPRESENTS OUR INITIAL/FINAL REPORT.