MIRROR - DBL SIDED, SZ 5

Additional Manufacturer Narrative

ON 7/29/16 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE RETURNED MIRROR SHOWS SCRATCHED REFLECTIVE SURFACE AND DETACHED FROM FRAMES. WHILE INSPECTING THE MIRROR IT IS ALSO NOTICED THAT THE MIRROR IS DETACHED AND HAVE FALLEN OUT OF FRAME . WITHOUT KNOWING WHAT TEMPERATURES WERE USED WHEN IN AUTOCLAVE AND HOW THE MIRROR WAS HANDLED DURING WIPING; THE CAUSE IS UNDETERMINED. THIS TYPE OF DAMAGE CAN HAPPEN WHEN HEAT PENETRATES THE REFLECTIVE SURFACE DURING AUTOCLAVING. THE COMPLAINT REPORT IS CONFIRMED. DEVICE HISTORY EVALUATION - DHR REVIEW: NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: ISSUED FOR THE MIRROR GLASS BECOMING SEPARATED FROM THE MIRROR FRAME. ISSUED FOR DOUBLE SIDE MIRROR GLASS SEPARATING FORM THE FRAME. HEALTH HAZARD EVALUATION HISTORY: ISSUED FOR THE FOLLOWING REASONS: MIRROR DETACHING FROM THE FRAME. CONCLUSION: THE ROOT CAUSE HAS BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY. APPROPRIATE ACTION HAS BEEN IMPLEMENTED TO RECTIFY THIS MANUFACTURING DEFICIENCY.

Description of Event or Problem

CUSTOMER INITIALLY REPORTS MIRRORS ARE COMING OFF OF THE SURFACE, COMING UNGLUED. FELL OFF IN PATIENTS MOUTHS. ON (B)(6) 2016 CUSTOMER REPORTS NO HARM DONE. THIS IS #3 OF 3 RELATED COMPLAINTS.