PENTAX
Received Apr 18, 2023 · Event occurred Mar 20, 2023
Report 9610877-2023-53614 · MDR key 16758945
Device
Product problems
- No Display/Image
- No Display/Image
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT. THEREFORE, 510K IS NOT APPLICABLE. MODEL EE-1580K IS AVAILABLE IN THE USA, WITH A 510K NUMBER K961564. THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED, THAT THE CCD MODULE WITH DRIVE PCB BLACKOUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED, DUE TO THE PHYSICAL DAMAGE APPLIED ON THE CCD MODULE WITH DRIVE PCB. BASED ON THE TECHNICAL REPORT "HR-RPT-0586(IMAGE FAILURE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.
Description of Event or Problem
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).