inforMED
MalfunctionFAM

PENTAX

Received Jul 21, 2022 · Event occurred Jun 24, 2022

Report 9610877-2022-55879 · MDR key 15071450

Device

Generic name

Video Sigmoidoscope 4.2c 12.8t 700l Fwj

Model number

ES-3870K

Product problems

  • Optical Distortion
  • Optical Distortion

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE LENS UNIT CLOUDY (NOT CLEAR VIEW). BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE MOISTURE CONDENSATION IN THE OBJECTIVE LENS UNIT. IN ADDITION, WE CONFIRMED THAT THE INSERTION FLEXIBLE TUBE (IFT) COATING DAMAGE, THE WATER NOZZLE CLOGGED, THE INSERTION FLEXIBLE TUBE (IFT) BUMP, THE ANGLE WIRE GRINDING, AND THE AIR/WATER SOCKET CHIPPED/CUT O-RING; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. 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 UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(CLOUDY).