MalfunctionGCL
PENTAX
Received Oct 26, 2022 · Event occurred Oct 4, 2022
Report 9610877-2022-59272 · MDR key 15678075
Device
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
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. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE AS DEFECTIVE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE. BASED ON THE TECHNICAL REPORT "HR-RPT-0586(IMAGE FAILURE)" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.