GASTROINTESTINAL VIDEOSCOPE GIF-XP150N (UDI 04953170307478)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170307478), received between Mar 31, 2022 and May 31, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Corroded

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED CORROSION ON CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342469 ↗
• MalfunctionApr 3, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CORROSION ON LIGHT GUIDE COVER GLASS AND ELECTRICAL CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778728 ↗
• MalfunctionApr 2, 2026Difficult to Insert

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE'S FORCEPS CANNOT BE INSERTED SMOOTHLY DUE TO A DENT ON CHANNEL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24763852 ↗
• MalfunctionMar 3, 2026Poor Quality Image; Failure to Clean Adequately

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500114 ↗
• MalfunctionFeb 6, 2026Corroded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CORROSION UNDER THE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24281731 ↗
• MalfunctionJan 21, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON THE SCOPE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128100 ↗
• MalfunctionSep 9, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A FOREIGN OBJECT IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011943 ↗
• MalfunctionJun 11, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181795 ↗
• MalfunctionMar 28, 2025Collapse; Corroded; Crack; Difficult or Delayed Positioning; Positioning Failure; Material Discolored; Residue After Decontamination; Gas/Air Leak; Scratched Material; Device Fell; Collapse; Corroded; Crack; Difficult or Delayed Positioning; Positioning Failure; Material Discolored; Residue After Decontamination; Gas/Air Leak; Scratched Material; Device Fell

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED THE DISTAL END HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21724171 ↗
• MalfunctionFeb 20, 2025Failure to Clean Adequately; Failure to Clean Adequately

  DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. CLEANING DISINFECTION AND STERILIZATION (CDS) WAS SUPPLIED BY THE CUSTOMER: THE DEVICE WAS REPROCESSED AT PICKUP. HOWEVER, THE PRECLEANING STEP OF AIR-WATER CHANNEL FLUSHING SEEMS TO BE MISSING AT TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423541 ↗
• MalfunctionNov 9, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOSCOPE WAS USED WITH A OLYMPUS ENDOSCOPE REPROCESSOR THAT RECEIVED AN E01 ERROR CODE (FILLING THE BASIN WITH WATER TOOK TOO LONG). THE FACILITY CONFIRMED THAT THE WATER FILTER HAD NOT BEEN REPLACED IN OVER A MONTH. THERE WERE NO REPORTS OF PATIENT HARM. THIS REPORT IS LINKED TO THE PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108085 ↗
• MalfunctionApr 22, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A GASTROINTESTINAL VIDEOSCOPE, THERE WERE AIR/WATER FLOW ISSUES FROM THE AIR/WATER SYSTEM. THE PROBLEM WAS IDENTIFIED ON INSPECTION FOR USE. THE INTENDED PROCEDURE WAS COMPLETED. THE INTENDED PROCEDURE IS UNKNOWN. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND UPON ESTIMATION, THERE WAS FOREIGN MATTER FOUND CLOGGING THE NOZZLE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792696 ↗
• MalfunctionApr 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR A GASTROINTESTINAL VIDEOSCOPE, HAVING BAD ANGLE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, FOREIGN MATERIAL WAS FOUND CLOGGED IN THE SCOPE AIR/WATER NOZZLE DUE TO INSUFFICIENT CLEANING. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728125 ↗
• MalfunctionApr 5, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THE IMAGE FROM THE SUBJECT DEVICE WAS SLIGHTLY BLURRY, THERE WAS A LEAK BETWEEN THE ELECTRICAL CONNECTOR AND SCOPE CONNECTOR, AND ANGULATION WAS REDUCED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE ALLEGATION OF A BLURRY IMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686673 ↗
• MalfunctionMar 23, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THAT, DURING REPROCESSING, THE SUBJECT DEVICE HAD LEAKAGE FROM THE BENDING SECTION COVER. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE IMAGE WAS BLURRED. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BLURRED IMAGE). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600815 ↗
• MalfunctionMar 2, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE HAD AN ANGLE WIRE BREAK. THE DEVICE WAS RETURNED TO SERVICE WHERE EVALUATION FOUND THE DEVICE WAS DISPLAYING A BLURRY IMAGE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469699 ↗
• MalfunctionMar 1, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  DURING AN ASSET RETURN INSPECTION WITH NO COMPLAINT RECEIVED FROM THE CUSTOMER, CLOGGED NOZZLE WAS OBSERVED. FOREIGN MATERIAL WAS FOUND INSIDE THE NOZZLE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO HARM WAS REPORTED. NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16465046 ↗
• MalfunctionDec 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE OLYMPUS REPRESENTATIVE REPORTED THAT DURING A DIAGNOSTIC UPPER ENDOSCOPY PROCEDURE, THE GASTROINTESTINAL VIDEOSCOPE PRESENTED WITH A LATERAL NOISE THAT ENTERED THE OCTAGONAL SCREEN OF THE ENDOSCOPE DURING THE PROCEDURE AND DISPLAYED ERROR CODE E311 (WHITE BALANCE NOT SET). THE ENDOSCOPE SCREEN HAD APPEARED AND DISAPPEARED. THERE WAS A POSSIBILITY THAT THE CONTACT ON THE SCOPE CABLE WAS POOR, SO THE USER TRIED DISCONNECTING AND RECONNECTING THE CABLE, BUT THE ISSUE DID NOT IMPROVE. THEREFORE, WHEN CHECKED USING A SIMPLE WATER LEAKAGE CHECKER, IT WAS FOUND THAT AIR AND WATER LEAKAGE BUBBLES WERE COMING OUT OF THE SCOPE CONNECTOR STOPPER, AND THERE WAS A GAP. THE PROCEDURE WAS CANCELLED. THE CUSTOMER CONFIRMED THERE WAS NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977277 ↗
• MalfunctionNov 17, 2022Failure to Clean Adequately; Failure to Clean Adequately

  OLYMPUS (OMSC) WAS INFORMED THAT THE CUSTOMER GASTROINTESTINAL VIDEOSCOPE WAS RETURNED TO THE OLYMPUS REPAIR CENTER FOR A REPORTED ¿CLOGGING OF AIR/WATER SUPPLY¿. THE CUSTOMER REPORTED ISSUE WAS FOUND DURING AN UNSPECIFIED EVENT. DURING THE REPAIR INSPECTION, FOREIGN MATERIAL WAS FOUND CLOGGED INSIDE THE AIR/WATER NOZZLE AT THE DISTAL END OF THE SCOPE. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE FOREIGN MATERIAL WAS FOUND CLOGGED INSIDE THE AIR/WATER NOZZLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815373 ↗
• MalfunctionMar 31, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT NOZZLE CLOGGING OCCURRED WITH THE GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. DURING THE EVALUATION OF THE DEVICE, A FOREIGN MATERIAL CAME OUT OF THE SCOPE. THIS MDR IS BEING FILED AS MDR BASED ON THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971658 ↗