PENTAX
Received Oct 28, 2021 · Event occurred Oct 11, 2021
Report 9610877-2021-01316 · MDR key 12716519
Device
Product problems
- Erratic or Intermittent Display
- Optical Distortion
- Erratic or Intermittent Display
- Optical Distortion
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CORRECTION INFORMATION G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION H4:DEVICE MANUFACTURE DATE EVALUATION SUMMARY THE DEVICE HAS BEEN REPAIRED AND THE CCD HAS BEEN REPLACED.
Description of Event or Problem
IMAGE DISTURBANCE DURING ANGULATION. ALSO WITH TEST PCB. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.
Additional Manufacturer Narrative
IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE.