inforMED
MalfunctionGCQ

PENTAX

Received Jun 30, 2022 · Event occurred Jun 7, 2022

Report 9610877-2022-00515 · MDR key 14868620

Device

Generic name

Endoscope

Product problems

  • Optical Distortion
  • Optical Distortion

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

CUSTOMER REPORTED BLURRY PICTURE AND THERE WAS A BIG WHITE SPOT ON THE LENS. THE TIME OF EVENT IS UNKNOWN. 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 NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE.

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. EVALUATION SUMMARY: IT IS PRESUMED THAT THE PHENOMENON WAS CAUSED BY THE BLURRING OF THE IMAGE DUE TO DIRT ON THE LENS SURFACE. REGARDING THIS PHENOMENON, WE HAVE DETERMINED THAT IT MAY BE DIFFICULT TO REMOVE DIRT FROM THE LENS DUE TO ENVIRONMENTAL FACTORS.