GASTROINTESTINAL FIBERSCOPE OLYMPUS GIF TYPE E3 (UDI 04953170307355)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170307355), received between Oct 2, 2020 and Sep 11, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (4 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Thermal Decomposition of Device

  The customer reported a burn on the plastic distal end cover during inspection for use involving an Olympus gastrointestinal fiberscope. There was no patient injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50738643 ↗
• MalfunctionJun 10, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL FIBERSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPORT TECHNICIAN INDICATES THAT DIRT IN THE FIELD VISION WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460154 ↗
• MalfunctionFeb 16, 2026Corroded; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL FIBERSCOPE HAD DIRT IN THE OPTICAL PART AND RUST UNDER THE LENSES (BACKLIGHT). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343645 ↗
• MalfunctionOct 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL FIBERSCOPE EXHIBITED A BLOCKED UP/DOWN HANDLE STOPPER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297286 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRY IMAGE. THE ISSUE WAS FOUND DURING SERVICE / MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276665 ↗
• MalfunctionDec 9, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE WORKING CHANNEL WAS BLOCKED ON THE GASTROINTESTINAL FIBERSCOPE. THE ISSUE OCCURRED DURING REPROCESSING AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE NOZZLE WAS FOUND TO BE CLOGGED WITH FOREIGN MATERIAL. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15950011 ↗
• MalfunctionNov 11, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL FIBERSCOPE HAD AN IMAGE PROBLEM. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THERE WAS DIRT ON THE BENDING SECTION RUBBER, THE GRIP, THE RIGHT/LEFT KNOB, AND THE UP/DOWN KNOB, WHICH IS INDICATIVE OF INSUFFICIENT OR INCORRECT REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15782630 ↗
• MalfunctionOct 2, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. DISTAL END: STAPHYLOCOCCUS WARNERI (1 CFU) INSTRUMENT CHANNEL: ESCHERICHIA COLI (68 CFU), PSEUDOMONAS AERUGINOSA (41 CFU), SERRATIA MARCESCENS (2 CFU) THE DEVICE HAD BEEN REPROCESSED WITH A STEELCO AUTOMATED ENDOSCOPE REPROCESSOR MODEL EW 2/2, USING NEODISHER SEPTO PAC. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10620155 ↗