MIRROR - DBL SIDED, SZ 4
Received Aug 31, 2017
Report 2523190-2017-00086 · MDR key 6835667
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
9/5/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. UNCONFIRMED/NO RETURN OF DEVICE FOR EVALUATION. DEVICE HISTORY EVALUATION: 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/CORRECTIONS: CAPA (B)(4) ISSUED (B)(6) 2015 FOR MIRRORS SEPARATING FROM FRAME AND CAPA (B)(4) ISSUED (B)(6) 2011. HEALTH HAZARD EVALUATION HISTORY: (B)(4) DEC. 2012 DUE TO GLASS SEPARATION AND (B)(4) MAY 2010 FOR MIRRORS DISLODGING FROM FRAME. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem
CUSTOMER INITIALLY REPORTS MIRRORS CAME OFF. ON (B)(6) 2017 DOCTOR REPORTS NO HARM DONE.