VIDEO COLONOSCOPE EC34-I10TLRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333242900), received between Nov 13, 2020 and Nov 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Optical Distortion” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2020Optical Distortion; Optical Distortion

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED AT A FACILITY IN (B)(6). AN MDPR WAS FILED WITH (B)(6). THE REPORTED INFORMATION IS AS FOLLOWS: THE HOSPITAL REPORTS, "THE FLEET OF PENTAX HIGH-DEFINITION COLONOSCOPES AND GASTROSCOPES AT JIM PATTISON OUTPATIENT CARE AND SURGERY CENTRE HAVE EXHIBITED ISSUES WHERE BLURRY ARTIFACTS ARE PRESENT IN ENDOSCOPY PROCEDURE IMAGES. THESE ARTIFACTS OBSCURE PARTS OF THE IMAGE AND LIMIT THE ABILITY OF STAFF TO CLEARLY IDENTIFY REGIONS OF INTEREST, SUCH AS POTENTIALLY CANCEROUS POLYPS. THE PREVALENCE OF THIS PROBLEM HAS BECOME A PATIENT SAFETY ISSUE, AS PATIENTS MAY RECEIVE FALSE NEGATIVE TEST RESULTS IN THE EVENT THAT A REGION OF INTEREST IS MISSED. TO UPDATE, 139 INCIDENT EVENTS HAVE BEEN REPORTED TO THE BC PATIENT SAFETY AND LEARNING SYSTEM REGARDING ISSUES WITH THIS FLEET OF SCOPES. IN AN EFFORT TO IDENTIFY THE ROOT CAUSE OF THIS PROBLEM, BIOMEDICAL ENGINEER HAS PARTNERED WITH ENDOSCOPY CLINICAL STAFF, MEDICAL DEVICE REPROCESSING DEPARTMENT LEADERSHIP, AND PENTAX TO CONDUCT A SYSTEMATIC VARIABLE-BY-VARIABLE INVESTIGATION. AT THE TIME OF THIS WRITING, THE INVESTIGATION GROUP HAS CONDUCTED LABORATORY ANALYSIS AND SITE WATER TESTING TO IDE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10837285 ↗